MDR Audit Checklist

Description:

Validity of certificates

Article 120(1)

From ►M1 26 May 2021 ◄ , any publication of a notification in respect of a notified body in accordance with Directives 90/385/EEC and 93/42/EEC shall become void.

Article 120(2)

Certificates issued by notified bodies in accordance with Directives 90/385/EEC and 93/42/EEC prior to 25 May 2017 shall remain valid until the end of the period indicated on the certificate, except for certificates issued in accordance with Annex 4 to Directive 90/385/EEC or Annex IV to Directive 93/42/EEC which shall become void at the latest on 27 May 2022.

Article 120(2)

Certificates issued by notified bodies in accordance with Directives 90/385/EEC and 93/42/EEC from 25 May 2017 that were still valid on 26 May 2021 and that have not been withdrawn afterwards shall remain valid after the end of the period indicated on the certificate until the date set out in paragraph 3a of this Article applicable for the relevant risk class of the devices. Certificates issued by notified bodies in accordance with those Directives from 25 May 2017 that were still valid on 26 May 2021 and that have expired before 20 March 2023 shall be considered to be valid until the dates set out in paragraph 3a of this Article only if one of the following conditions is fulfilled:

1. before the date of expiry of the certificate, the manufacturer and a notified body have signed a written agreement in accordance with Section 4.3, second subparagraph, of Annex VII to this Regulation for the conformity assessment in respect of the device covered by the expired certificate or in respect of a device intended to substitute that device;
2. a competent authority of a Member State has granted a derogation from the applicable conformity assessment procedure in accordance with Article 59(1) of this Regulation or has required the manufacturer, in accordance with Article 97(1) of this Regulation, to carry out the applicable conformity assessment procedure.

Old devices

Article 120(10)

Devices falling within the scope of this Regulation in accordance with point (g) of Article 1(6) which have been legally placed on the market or put into service in accordance with the rules in force in the Member States prior to 26 May 2021 may continue to be placed on the market and put into service in the Member States concerned.

Legacy devices

Article 120(3)

By way of derogation from Article 5 and provided the conditions set out in paragraph 3c of this Article are met, devices referred to in paragraphs 3a and 3b of this Article may be placed on the market or put into service until the dates set out in those paragraphs.

Article 120(3a)

Devices which have a certificate that was issued in accordance with Directive 90/385/EEC or Directive 93/42/EEC and that is valid by virtue of paragraph 2 of this Article may be placed on the market or put into service until the following dates:

1. 31 December 2027, for all class III devices, and for class IIb implantable devices except sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors;
2. 31 December 2028, for class IIb devices other than those covered by point (a) of this paragraph, for class IIa devices, and for class I devices placed on the market in sterile condition or having a measuring function.

Article 120(3b)

Devices for which the conformity assessment procedure pursuant to Directive 93/42/EEC did not require the involvement of a notified body, for which the declaration of conformity was drawn up prior to 26 May 2021 and for which the conformity assessment procedure pursuant to this Regulation requires the involvement of a notified body, may be placed on the market or put into service until 31 December 2028.

Article 120(3f)

By way of derogation from Article 5, class III custom-made implantable devices may be placed on the market or put into service until 26 May 2026 without a certificate issued by a notified body in accordance with the conformity assessment procedure referred to in Article 52(8), second subparagraph, provided that no later than 26 May 2024, the manufacturer or the authorised representative has lodged a formal application with a notified body in accordance with Section 4.3, first subparagraph, of Annex VII for conformity assessment, and, no later than 26 September 2024, the notified body and the manufacturer have signed a written agreement in accordance with Section 4.3, second subparagraph, of Annex VII.

Article 120(4)

Devices lawfully placed on the market pursuant to Directives 90/385/EEC and 93/42/EEC prior to 26 May 2021, and devices lawfully placed on the market from 26 May 2021 pursuant to paragraphs 3, 3a, 3b and 3f of this Article, may continue to be made available on the market or put into service.

Conditions for legacy devices

Article 120(3c)

Devices referred to in paragraphs 3a and 3b of this Article may be placed on the market or put into service until the dates referred to in those paragraphs only if the following conditions are met:

1. (a) those devices continue to comply with Directive 90/385/EEC or Directive 93/42/EEC, as applicable;
2. (b) there are no significant changes in the design and intended purpose;
3. (c) the devices do not present an unacceptable risk to the health or safety of patients, users or other persons, or to other aspects of the protection of public health;
4. (d) no later than 26 May 2024, the manufacturer has put in place a quality management system in accordance with Article 10(9);
5. (e) no later than 26 May 2024, the manufacturer or the authorised representative has lodged a formal application with a notified body in accordance with Section 4.3, first subparagraph, of Annex VII for conformity assessment in respect of a device referred to in paragraph 3a or 3b of this Article or in respect of a device intended to substitute that device, and, no later than 26 September 2024, the notified body and the manufacturer have signed a written agreement in accordance with Section 4.3, second subparagraph, of Annex VII.

Article 120(3d)

By way of derogation from paragraph 3 of this Article, the requirements of this Regulation relating to post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices shall apply to devices referred to in paragraphs 3a and 3b of this Article in place of the corresponding requirements in Directives 90/385/EEC and 93/42/EEC.

Article 120(3e)

No later than 26 September 2024, the notified body that has signed the written agreement referred to in paragraph 3c, point (e), of this Article shall be responsible for the surveillance in respect of the devices covered by the written agreement. Where the written agreement covers a device intended to substitute a device which has a certificate that was issued in accordance with Directive 90/385/EEC or Directive 93/42/EEC, the surveillance shall be conducted in respect of the device that is being substituted.

Surveillance by NB

Article 120(3e)

Without prejudice to Chapter IV and paragraph 1 of this Article, the notified body that issued the certificate referred to in paragraph 3a of this Article shall continue to be responsible for the appropriate surveillance in respect of the applicable requirements relating to the devices it has certified, unless the manufacturer has agreed with a notified body designated in accordance with Article 42 that the latter shall carry out such surveillance.

The arrangements for the transfer of the surveillance from the notified body that issued the certificate to the notified body designated in accordance with Article 42 shall be clearly defined in an agreement between the manufacturer and the notified body designated in accordance with Article 42 and, where practicable, the notified body that issued the certificate. The notified body designated in accordance with Article 42 shall not be responsible for conformity assessment activities carried out by the notified body that issued the certificate.

EUDAMED

Article 123(d)

Until Eudamed is fully functional, the corresponding provisions of Directives 90/385/EEC and 93/42/EEC shall continue to apply for the purpose of meeting the obligations laid down in the provisions listed in the first paragraph of this point regarding exchange of information including, and in particular, information regarding vigilance reporting, clinical investigations, registration of devices and economic operators, and certificate notifications.

Article 123(3d)

the obligations and requirements that relate to any of the EUDAMED modules referred to in Article 33(2) shall apply from the date corresponding to 6 months from the date of publication of the notice referred to in Article 34(3), informing that the relevant module is functional and meets the functional specifications drawn up pursuant to Article 34(1).

Until the date of application of the provisions referred to in the first subparagraph of this point, the corresponding provisions of Directives 90/385/EEC and 93/42/EEC regarding information on vigilance reporting, clinical investigations, registration of devices and economic operators, and certificate notifications shall continue to apply.

Article 123(3e)

Device/UDI module

No later than 12 months from the date of publication of the notice referred to in Article 34(3) in respect of EUDAMED for device/UDI registration, manufacturers shall ensure that the information to be entered in Eudamed in accordance with Article 29 is entered in that electronic system, including regarding the following devices, provided that those devices are also placed on the market from 6 months from the date of publication of that notice:

• devices, other than custom-made devices, for which the manu facturer has undertaken a conformity assessment in accordance with Article 52;
• devices, other than custom-made devices, placed on the market pursuant to Article 120(3), (3a) or (3b), unless the device, for which the manufacturer has undertaken a conformity assessment in accordance with Article 52, is already registered in Eudamed

Article 123(ea)

NB/Certificate module

no later than 18 months from the date of publication of the notice referred to in Article 34(3) in respect of the electronic system for Certificate, notified bodies shall ensure that the information to be entered in Eudamed in accordance with Article 56(5) is entered in that electronic system, including regarding devices referred to in point (e)(i) of this paragraph; for those devices, only the latest relevant certificate and, where applicable, any subsequent decision taken by the notified body related to such certificate shall be entered;

Article 123(eb)

by way of derogation from point (d), first subparagraph, of this paragraph, the obligations to upload the summary of safety and clinical performance in accordance with Article 32(1) and to notify competent authorities in accordance with Article 55(1), through the electronic system referred in Article 33(2), point (d), shall apply to devices referred to in point (e) of this paragraph when the certifi cate is entered in Eudamed in accordance with point (ea) of this paragraph;

Article 123(ec)

without prejudice to point (d), first subparagraph, of this paragraph, when a manufacturer is to submit a PSUR in accordance with Article 86(2) of this Regulation, to report a serious incident or a field safety corrective action in accordance with Article 87 of this Regulation, or to submit a trend report in accordance with Article 88 of this Regulation through the electronic system referred to in Article 33(2), point (f), of this Regulation, it shall also register the device, which is the subject of the PSUR or the vigilance reporting, in the electronic system referred to in Article 33(2), points (a) and (b), of this Regulation, except if such device was placed on the market in accordance with Directive 90/385/EEC or 93/42/EEC;

Description:

Definition

Article 1(8)

Any device which, when placed on the market or put into service, incorporates, as an integral part, a substance which, if used separately, would be considered to be a medicinal product as defined in point 2 of Article 1 of Directive 2001/83/EC, including a medicinal product derived from human blood or human plasma as defined in point 10 of Article 1 of that Directive, and that has an action ancillary to that of the device, shall be assessed and authorised in accordance with this Regulation.

However, if the action of that substance is principal and not ancillary to that of the device, the integral product shall be governed by Directive 2001/83/EC or Regulation (EC) No 726/2004 of the European Parliament and of the Council ( 1 ), as applicable. In that case, the relevant general safety and performance requirements set out in Annex I to this Regulation shall apply as far as the safety and performance of the device part are concerned.

Article 1(9)

Any device which is intended to administer a medicinal product as defined in point 2 of Article 1 of Directive 2001/83/EC shall be governed by this Regulation, without prejudice to the provisions of that Directive and of Regulation (EC) No 726/2004 with regard to the medicinal product.

However, if the device intended to administer a medicinal product and the medicinal product are placed on the market in such a way that they form a single integral product which is intended exclusively for use in the given combination and which is not reusable, that single integral product shall be governed by Directive 2001/83/EC or Regulation (EC) No 726/2004, as applicable. In that case, the relevant general safety and performance requirements set out in Annex I to this Regulation shall apply as far as the safety and performance of the device part of the single integral product are concerned.

No need of NB Opinion

Article 117

Where, in accordance with the second subparagraph of Article 1(8) or the second subparagraph of Article 1(9) of Regulation (EU) 2017/745 of the European Parliament and of the Council ( *1 ), a product is governed by this Directive, the marketing authorisation dossier shall include, where available, the results of the assessment of the conformity of the device part with the relevant general safety and performance requirements set out in Annex I to that Regulation contained in the manufacturer’s EU declaration of conformity or the relevant certificate issued by a notified body allowing the manufacturer to affix a CE marking to the medical device.

Need of NB Opinion

Article 117

If the dossier does not include the results of the conformity assessment referred to in the first subparagraph and where for the conformity assessment of the device, if used separately, the involvement of a notified body is required in accordance with Regulation (EU) 2017/745, the authority shall require the applicant to provide an opinion on the conformity of the device part with the relevant general safety and performance requirements set out in Annex I to that Regulation issued by a notified body designated in accordance with that Regulation for the type of device in question.

Description:

General requirements

Article 10(5)

Manufacturers of custom-made devices shall draw up, keep up to date and keep available for competent authorities documentation in accordance with Section 2 of Annex XIII.

Article 21(1b)

Member States shall not create obstacles to custom-made devices being made available on the market if Article 52(8) and Annex XIII have been complied with.

Article 21(1)

No CE marking

The devices referred to in the first subparagraph shall not bear the CE marking, with the exception of the devices referred to in Article 74.

Article 21(2)

Statement

Custom-made devices shall be accompanied by the statement referred to in Section 1 of Annex XIII, which shall be made available to the particular patient or user identified by name, an acronym or a numerical code.

Article 21(2)

Device registration

Member States may require that the manufacturer of a custom-made device submit to the competent authority a list of such devices which have been made available in their territory.

Custom-made device statement

Annex XIII(1)

For custom-made devices, the manufacturer or its authorised representative shall draw up a statement containing all of the following information:

• the name and address of the manufacturer, and of all manufacturing sites,
• if applicable, the name and address of the authorised representative,
• data allowing identification of the device in question,
• a statement that the device is intended for exclusive use by a particular patient or user, identified by name, an acronym or a numerical code,
• the name of the person who made out the prescription and who is authorised by national law by virtue of their professional qualifications to do so, and, where applicable, the name of the health institution concerned,
• the specific characteristics of the product as indicated by the prescription,
• a statement that the device in question conforms to the general safety and performance requirements set out in Annex I and, where applicable, indicating which general safety and performance requirements have not been fully met, together with the grounds,
• where applicable, an indication that the device contains or incorporates a medicinal substance, including a human blood or plasma derivative, or tissues or cells of human origin, or of animal origin as referred to in Regulation (EU) No 722/2012.

Custom-made device documentation

Annex XIII(2)

The manufacturer shall undertake to keep available for the competent national authorities documentation that indicates its manufacturing site or sites and allows an understanding to be formed of the design, manufacture and performance of the device, including the expected performance, so as to allow assessment of conformity with the requirements of this Regulation.

Annex XIII(3)

The manufacturer shall take all the measures necessary to ensure that the manufacturing process produces devices which are manufactured in accordance with the documentation referred to in Section 2.

Retention policy

Annex XIII(4)

The statement referred to in the introductory part of Section 1 shall be kept for a period of at least 10 years after the device has been placed on the market. In the case of implantable devices, the period shall be at least 15 years.

PMS

Annex XIII(5)

The manufacturer shall review and document experience gained in the post-production phase, including from PMCF as referred to in Part B of Annex XIV, and implement appropriate means to apply any necessary corrective action, In that context, it shall report in accordance with Article 87(1) to the competent authorities any serious incidents or field safety corrective actions or both as soon as it learns of them.

Description:

Definition

Annex XV

The device is part of the groups of products without medical purpose

Annex XV(1)

• Contact lenses or other items intended to be introduced into or onto the eye.

Annex XV(2)

• Products intended to be totally or partially introduced into the human body through surgically invasive means for the purpose of modifying the anatomy or fixation of body parts with the exception of tattooing products and piercings.

Annex XV(3)

• Substances, combinations of substances, or items intended to be used for facial or other dermal or mucous membrane filling by subcutaneous, submucous or intradermal injection or other introduction, excluding those for tattooing.

Annex XV(4)

• Equipment intended to be used to reduce, remove or destroy adipose tissue, such as equipment for liposuction, lipolysis or lipoplasty.

Annex XV(5)

• High intensity electromagnetic radiation (e.g. infra-red, visible light and ultra-violet) emitting equipment intended for use on the human body, including coherent and non-coherent sources, monochromatic and broad spectrum, such as lasers and intense pulsed light equipment, for skin resurfacing, tattoo or hair removal or other skin treatment.

Annex XV(6)

• Equipment intended for brain stimulation that apply electrical currents or magnetic or electromagnetic fields that penetrate the cranium to modify neuronal activity in the brain.

Common specifications

(EU) 2022/2346

The device meets the requirements from the Commission Implementing Regulation (EU) 2022/2346 – Common specifications for the groups of products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745

Description:

Article 21(1a)

Member States shall not create obstacles to investigational devices being supplied to an investigator for the purpose of a clinical investigation if they meet the conditions laid down in Articles 62 to 80 and Article 82, in the implementing acts adopted pursuant to Article 81 and in Annex XV;

Article 21(1)

The devices referred to in the first subparagraph shall not bear the CE marking, with the exception of the devices referred to in Article 74.

Description:

Definition

Article 22(1)

Natural or legal persons shall draw up a statement if they combine devices bearing a CE marking with the following other devices or products, in a manner that is compatible with the intended purpose of the devices or other products and within the limits of use specified by their manufacturers, in order to place them on the market as a system or procedure pack:

Article 22(1a)

• other devices bearing the CE marking;

Article 22(1b)

• in vitro diagnostic medical devices bearing the CE marking in conformity with Regulation (EU) 2017/746;

Article 22(1c)

• other products which are in conformity with legislation that applies to those products only where they are used within a medical procedure or their presence in the system or procedure pack is otherwise justified.

Statement

Article 22(2)

In the statement made pursuant to paragraph 1, the natural or legal person concerned shall declare that:

Article 22(2a)

they verified the mutual compatibility of the devices and, if applicable other products, in accordance with the manufacturers’ instructions and have carried out their activities in accordance with those instructions;

Article 22(2b)

they packaged the system or procedure pack and supplied relevant information to users incorporating the information to be supplied by the manufacturers of the devices or other products which have been put together;

Article 22(2c)

the activity of combining devices and, if applicable, other products as a system or procedure pack was subject to appropriate methods of internal monitoring, verification and validation.

Case of sterilization

Article 22(3)

Any natural or legal person who sterilises systems or procedure packs referred to in paragraph 1 for the purpose of placing them on the market shall, at their choice, apply one of the procedures set out in Annex IX or the procedure set out in Part A of Annex XI. The application of those procedures and the involvement of the notified body shall be limited to the aspects of the procedure relating to ensuring sterility until the sterile packaging is opened or damaged. The natural or legal person shall draw up a statement declaring that sterilisation has been carried out in accordance with the manufacturer’s instructions.

When procedure pack does not apply

Article 22(4)

Where the system or procedure pack incorporates devices which do not bear the CE marking or where the chosen combination of devices is not compatible in view of their original intended purpose, or where the sterilisation has not been carried out in accordance with the manufacturer’s instructions, the system or procedure pack shall be treated as a device in its own right and shall be subject to the relevant conformity assessment procedure pursuant to Article 52. The natural or legal person shall assume the obligations incumbent on manufacturers.

CE marking and labeling requirements

Article 22(5)

The systems or procedure packs referred to in paragraph 1 of this Article shall not themselves bear an additional CE marking but they shall bear the name, registered trade name or registered trade mark of the person referred to in paragraphs 1 and 3 of this Article as well as the address at which that person can be contacted, so that the person’s location can be established. Systems or procedure packs shall be accompanied by the information referred to in Section 23 of Annex I. The statement referred to in paragraph 2 of this Article shall be kept at the disposal of the competent authorities, after the system or procedure pack has been put together, for the period that is applicable under Article 10(8) to the devices that have been combined. Where those periods differ, the longest period shall apply.

Description:

Article 23(1)

Any natural or legal person who makes available on the market an item specifically intended to replace an identical or similar integral part or component of a device that is defective or worn in order to maintain or restore the function of the device without changing its performance or safety characteristics or its intended purpose, shall ensure that the item does not adversely affect the safety and performance of the device. Supporting evidence shall be kept available for the competent authorities of the Member States.

Article 23(2)

An item that is intended specifically to replace a part or component of a device and that significantly changes the performance or safety characteristics or the intended purpose of the device shall be considered to be a device and shall meet the requirements laid down in this Regulation.

Description:

Article 17(1)

Reprocessing and further use of single-use devices may only take place where permitted by national law and only in accordance with this Article.

Article 17(2)

Any natural or legal person who reprocesses a single-use device to make it suitable for further use within the Union shall be considered to be the manufacturer of the reprocessed device and shall assume the obligations incumbent on manufacturers laid down in this Regulation, which include obligations relating to the traceability of the reprocessed device in accordance with Chapter III of this Regulation. The reprocessor of the device shall be considered to be a producer for the purpose of Article 3(1) of Directive 85/374/EEC.

Article 17(3)

By way of derogation from paragraph 2, as regards single-use devices that are reprocessed and used within a health institution, Member States may decide not to apply all of the rules relating to manufacturers’ obligations laid down in this Regulation provided that they ensure that:

Article 17(3a)

• the safety and performance of the reprocessed device is equivalent to that of the original device and the requirements in points (a), (b), (d), (e), (f), (g) and (h) of Article 5(5) are complied with;

Article 17(3b)

• the reprocessing is performed in accordance with CS detailing the requirements concerning:
  • risk management, including the analysis of the construction and material, related properties of the device (reverse engineering) and procedures to detect changes in the design of the original device as well as of its planned application after reprocessing,
  • the validation of procedures for the entire process, including cleaning steps,
  • the product release and performance testing,
  • the quality management system,
  • the reporting of incidents involving devices that have been reprocessed, and
  • the traceability of reprocessed devices.

Article 17(3)

Member States shall encourage, and may require, health institutions to provide information to patients on the use of reprocessed devices within the health institution and, where appropriate, any other relevant information on the reprocessed devices that patients are treated with.

Article 17(3)

Member States shall notify the Commission and the other Member States of the national provisions introduced pursuant to this paragraph and the grounds for introducing them. The Commission shall keep the information publicly available.

Article 17(4)

Member States may choose to apply the provisions referred to in paragraph 3 also as regards single-use devices that are reprocessed by an external reprocessor at the request of a health institution, provided that the reprocessed device in its entirety is returned to that health institution and the external reprocessor complies with the requirements referred to in points (a) and (b) of paragraph 3.

Article 17(5)

The Commission shall adopt, in accordance with Article 9(1), the necessary CS referred to in point (b) of paragraph 3 by ►M1 26 May 2021 ◄ . Those CS shall be consistent with the latest scientific evidence and shall address the application of the general requirements on safety and performance laid down in in this Regulation. In the event that those CS are not adopted by ►M1 26 May 2021 ◄ , reprocessing shall be performed in accordance with any relevant harmonised standards and national provisions that cover the aspects outlined in point (b) of paragraph 3. Compliance with CS or, in the absence of CS, with any relevant harmonised standards and national provisions, shall be certified by a notified body.

Article 17(6)

Only single-use devices that have been placed on the market in accordance with this Regulation, or prior to ►M1 26 May 2021 ◄ in accordance with Directive 93/42/EEC, may be reprocessed.

Article 17(7)

Only reprocessing of single-use devices that is considered safe according to the latest scientific evidence may be carried out.

Article 17(8)

The name and address of the legal or natural person referred to in paragraph 2 and the other relevant information referred to in Section 23 of Annex I shall be indicated on the label and, where applicable, in the instructions for use of the reprocessed device.

Article 17(8)

The name and address of the manufacturer of the original single-use device shall no longer appear on the label, but shall be mentioned in the instructions for use of the reprocessed device.

Article 17(9)

A Member State that permits reprocessing of single-use devices may maintain or introduce national provisions that are stricter than those laid down in this Regulation and which restrict or prohibit, within its territory, the following:

Article 17(9a)

• the reprocessing of single-use devices and the transfer of single-use devices to another Member State or to a third country with a view to their reprocessing;

Article 17(9b)

• the making available or further use of reprocessed single-use devices.

Article 17(9)

Member States shall notify the Commission and the other Member States of those national provisions. The Commission shall make such information publicly available.

Article 17(10)

The Commission shall by 27 May 2024 draw up a report on the operation of this Article and submit it to the European Parliament and to the Council. On the basis of that report, the Commission shall, if appropriate, make proposals for amendments to this Regulation.

Description:

Article 5(4)

Devices that are manufactured and used within health institutions shall be considered as having been put into service.

Restriction

Article 5(5)

With the exception of the relevant general safety and performance requirements set out in Annex I, the requirements of this Regulation shall not apply to devices, manufactured and used only within health institutions established in the Union, provided that all of the following conditions are met:

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–

Article 5(5)

1. the devices are not transferred to another legal entity,

Article 5(5)

1. manufacture and use of the devices occur under appropriate quality management systems,

Article 5(5)

1. the health institution justifies in its documentation that the target patient group’s specific needs cannot be met, or cannot be met at the appropriate level of performance by an equivalent device available on the market,

Article 5(5)

1. the health institution provides information upon request on the use of such devices to its competent authority, which shall include a justification of their manufacturing, modification and use;

Article 5(5)

1. the health institution draws up a declaration which it shall make publicly available, including:
   1. the name and address of the manufacturing health institution;
   2. the details necessary to identify the devices;
   3. a declaration that the devices meet the general safety and performance requirements set out in Annex I to this Regulation and, where applicable, information on which requirements are not fully met with a reasoned justification therefor,

Article 5(5)

1. the health institution draws up documentation that makes it possible to have an understanding of the manufacturing facility, the manufacturing process, the design and performance data of the devices, including the intended purpose, and that is sufficiently detailed to enable the competent authority to ascertain that the general safety and performance requirements set out in Annex I to this Regulation are met;

Article 5(5)

1. the health institution takes all necessary measures to ensure that all devices are manufactured in accordance with the documentation referred to in point (f), and

Article 5(5)

1. the health institution reviews experience gained from clinical use of the devices and takes all necessary corrective actions.

Communication to CA

Article 5(5)

Member States may require that such health institutions submit to the competent authority any further relevant information about such devices which have been manufactured and used on their territory.

Member States shall retain the right to restrict the manufacture and the use of any specific type of such devices and shall be permitted access to inspect the activities of the health institutions.

Additional requirements

Article 5(5)

Industrial scale

This paragraph shall not apply to devices that are manufactured on an industrial scale.

Article 5(6)

Implementing act

In order to ensure the uniform application of Annex I, the Commission may adopt implementing acts to the extent necessary to resolve issues of divergent interpretation and of practical application. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3).

UDI

Article 27(9)

Health institutions shall store and keep preferably by electronic means the UDI of the devices which they have supplied or with which they have been supplied, if those devices belong to class III implantable devices.

For devices other than class III implantable devices, Member States shall encourage, and may require, health institutions to store and keep, preferably by electronic means, the UDI of the devices with which they have been supplied.

Member States shall encourage, and may require, healthcare professionals to store and keep preferably by electronic means, the UDI of the devices with which they have been supplied with.

Description:

QMS procedure

Article 10(9a)

The QMS needs to consider a strategy for regulatory compliance, including compliance with conformity assessment procedures and procedures for management of modifications to the devices covered by the system

Device classification

Articles 51(1), (2), Annex VIII

Devices shall be divided into classes I, IIa, IIb and III, taking into account the intended purpose of the devices and their inherent risks. Classification shall be carried out in accordance with Annex VIII.

Note: Any dispute between the manufacturer and the notified body concerned, arising from the application of Annex VIII, shall be referred for a decision to the competent authority of the Member State in which the manufacturer has its registered place of business. In cases where the manufacturer has no registered place of business in the Union and has not yet designated an authorised representative, the matter shall be referred to the competent authority of the Member State in which the authorised representative referred to in the last indent of point (b) of the second paragraph of Section 2.2 of Annex IX has its registered place of business. Where the notified body concerned is established in a Member State other than that of the manufacturer, the competent authority shall adopt its decision after consultation with the competent authority of the Member State that designated the notified body.

Note: The competent authority of the Member State in which the manufacturer has its registered place of business shall notify the MDCG and the Commission of its decision. The decision shall be made available upon request.

Conformity assessment procedure

Articles 52, 54, 55

Is the conformity assessment procedure(s) selected relevant to the regulatory pathway discussed in Article 52 of the MDR?

Note: based on the device classification, TD per Annexes II/III and regulatory conformity assessment according to applicable annexes and sections from Annex IX to XI.

Note: external parties involved (EMA, CA or Expert panel) when a clinical evaluation consultation procedure (Annex IX Sect. 5.1 / Annex X Sect. 6) is required and based on the presence of

• medicinal substances (Annex IX 5.2)
• tissues or cells of human origin or their derivatives (Annex IX 5.3.1)
• tissues or cells of animal origin or their derivatives (Annex IX 5.3.2)

substances or of combinations of substances that are absorbed by or locally dispersed in the human body (Annex IX 5.4)

Article 53

Except for class I self-certified devices, has a NB be involved in the conformity assessment procedure?

Note: two different NB cannot be involved for the same device.

Annex IX

In the case of class III devices, the surveillance assessment shall also include a test of the approved parts and/or materials that are essential for the integrity of the device, including, where appropriate, a check that the quantities of produced or purchased parts and/or materials correspond to the quantities of finished devices.

Description:

Manufacturer obligations

Article 10(4)

Manufacturers of devices other than custom-made devices shall draw up and keep up to date technical documentation for those devices. The technical documentation shall be such as to allow the conformity of the device with the requirements of this Regulation to be assessed. The technical documentation shall include the elements set out in Annexes II and III.

UDI

Article 27(7)

As part of the technical documentation referred to in Annex II, the manufacturer shall keep up-to-date a list of all UDIs that it has assigned.

Technical Documentation File

Annex II(1.1a)

Device description and specification

• product or trade name and a general description of the device including its intended purpose and intended users;

Annex II(1.1b)

• the Basic UDI-DI as referred to in Part C of Annex VI assigned by the manufacturer to the device in question, as soon as identification of this device becomes based on a UDI system, or otherwise a clear identification by means of product code, catalogue number or other unambiguous reference allowing traceability;

Annex II(1.1c)

• the intended patient population and medical conditions to be diagnosed, treated and/or monitored and other considerations such as patient selection criteria, indications, contra-indications, warnings;

Annex II(1.1d)

• principles of operation of the device and its mode of action, scientifically demonstrated if necessary;

Annex II(1.1e)

• the rationale for the qualification of the product as a device;

Annex II(1.1f)

• the risk class of the device and the justification for the classification rule(s) applied in accordance with Annex VIII;

Annex II(1.1g)

• an explanation of any novel features;

Annex II(1.1h)

• a description of the accessories for a device, other devices and other products that are not devices, which are intended to be used in combination with it;

Annex II(1.1i)

• a description or complete list of the various configurations/variants of the device that are intended to be made available on the market;

Annex II(1.1j)

• a general description of the key functional elements, e.g. its parts/components (including software if appropriate), its formulation, its composition, its functionality and, where relevant, its qualitative and quantitative composition. Where appropriate, this shall include labelled pictorial representations (e.g. diagrams, photographs, and drawings), clearly indicating key parts/components, including sufficient explanation to understand the drawings and diagrams;

Annex II(1.1k)

• a description of the raw materials incorporated into key functional elements and those making either direct contact with the human body or indirect contact with the body, e.g., during extracorporeal circulation of body fluids;

Annex II(1.1l)

• technical specifications, such as features, dimensions and performance attributes, of the device and any variants/configurations and accessories that would typically appear in the product specification made available to the user, for example in brochures, catalogues and similar publications.

Annex II(1.2a)

Reference to previous and similar generations of the device

• an overview of the previous generation or generations of the device produced by the manufacturer, where such devices exist;

Annex II(1.2b)

• an overview of identified similar devices available on the Union or international markets, where such devices exist.

Annex II(2)

Information to be supplied by the manufacturer

A complete set of:

Annex II(2)

• the label or labels on the device and on its packaging, such as single unit packaging, sales packaging, transport packaging in case of specific management conditions, in the languages accepted in the Member States where the device is envisaged to be sold; and

Annex II(2)

• the instructions for use in the languages accepted in the Member States where the device is envisaged to be sold.

Annex II(3)

Design and manufacturing information

Annex II(3a)

• information to allow the design stages applied to the device to be understood;

Annex II(3b)

• complete information and specifications, including the manufacturing processes and their validation, their adjuvants, the continuous monitoring and the final product testing. Data shall be fully included in the technical documentation;

Annex II(3c)

• identification of all sites, including suppliers and sub-contractors, where design and manufacturing activities are performed.

Annex II(4)

GSPR

The documentation shall contain information for the demonstration of conformity with the general safety and performance requirements set out in Annex I that are applicable to the device taking into account its intended purpose, and shall include a justification, validation and verification of the solutions adopted to meet those requirements.

Annex II(6)

Product verification and validation

The documentation shall contain the results and critical analyses of all verifications and validation tests and/or studies undertaken to demonstrate conformity of the device with the requirements of this Regulation and in particular the applicable general safety and performance requirements.

Annex II(6.1a)

Pre-clinical and clinical data

• results of tests, such as engineering, laboratory, simulated use and animal tests, and evaluation of published literature applicable to the device, taking into account its intended purpose, or to similar devices, regarding the pre-clinical safety of the device and its conformity with the specifications;

Annex II(6.1b)

• detailed information regarding test design, complete test or study protocols, methods of data analysis, in addition to data summaries and test conclusions regarding in particular:
  • the biocompatibility of the device including the identification of all materials in direct or indirect contact with the patient or user;
  • physical, chemical and microbiological characterisation;
  • electrical safety and electromagnetic compatibility;
  • software verification and validation (describing the software design and development process and evidence of the validation of the software, as used in the finished device. This information shall typically include the summary results of all verification, validation and testing performed both in-house and in a simulated or actual user environment prior to final release. It shall also address all of the different hardware configurations and, where applicable, operating systems identified in the information supplied by the manufacturer);
  • stability, including shelf life; and
  • performance and safety.

Annex II(6.1b)

Where applicable, conformity with the provisions of Directive 2004/10/EC of the European Parliament and of the Council ( 9 ) shall be demonstrated

Annex II(6.1b)

Where no new testing has been undertaken, the documentation shall incorporate a rationale for that decision. An example of such a rationale would be that biocompatibility testing on identical materials was conducted when those materials were incorporated in a previous version of the device that has been legally placed on the market or put into service

Annex II(6.1c)

• the clinical evaluation report and its updates and the clinical evaluation plan referred to in Article 61(12) and Part A of Annex XIV;

Annex II(6.1d)

• the PMCF plan and PMCF evaluation report referred to in Part B of Annex XIV or a justification why a PMCF is not applicable.

Annex II(6.2a)

Additional information

• Where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product within the meaning of point 2 of Article 1 of Directive 2001/83/EC, including a medicinal product derived from human blood or human plasma, as referred to in the first subparagraph of Article 1(8), a statement indicating this fact. In this case, the documentation shall identify the source of that substance and contain the data of the tests conducted to assess its safety, quality and usefulness, taking account of the intended purpose of the device.

Annex II(6.2b)

• Where a device is manufactured utilising tissues or cells of human or animal origin, or their derivatives, and is covered by this Regulation in accordance with points (f) and (g) of Article 1(6, and where a device incorporates, as an integral part, tissues or cells of human origin or their derivatives that have an action ancillary to that of the device and is covered by this Regulation in accordance with the first subparagraph of Article 1(10), a statement indicating this fact. In such a case, the documentation shall identify all materials of human or animal origin used and provide detailed information concerning the conformity with Sections 13.1. or 13.2., respectively, of Annex I.

Annex II(6.2c)

• In the case of devices that are composed of substances or combinations of substances that are intended to be introduced into the human body and that are absorbed by or locally dispersed in the human body, detailed information, including test design, complete test or study protocols, methods of data analysis, and data summaries and test conclusions, regarding studies in relation to:
  • absorption, distribution, metabolism and excretion;
  • possible interactions of those substances, or of their products of metabolism in the human body, with other devices, medicinal products or other substances, considering the target population, and its associated medical conditions;
  • local tolerance; and
  • toxicity, including single-dose toxicity, repeat-dose toxicity, genotoxicity, carcinogenicity and reproductive and developmental toxicity, as applicable depending on the level and nature of exposure to the device.

In the absence of such studies, a justification shall be provided.

Annex II(6.2d)

• In the case of devices containing CMR or endocrine-disrupting substances referred to in Section 10.4.1 of Annex I, the justification referred to in Section 10.4.2 of that Annex.

Annex II(6.2e)

• In the case of devices placed on the market in a sterile or defined microbiological condition, a description of the environmental conditions for the relevant manufacturing steps. In the case of devices placed on the market in a sterile condition, a description of the methods used, including the validation reports, with respect to packaging, sterilisation and maintenance of sterility. The validation report shall address bioburden testing, pyrogen testing and, if applicable, testing for sterilant residues.

Annex II(6.2f)

• In the case of devices placed on the market with a measuring function, a description of the methods used in order to ensure the accuracy as given in the specifications.

Annex II(6.2g)

• If the device is to be connected to other device(s) in order to operate as intended, a description of this combination/configuration including proof that it conforms to the general safety and performance requirements when connected to any such device(s) having regard to the characteristics specified by the manufacturer.

Description:

QMS procedure

Article 10(1), 10(9b)

QMS needs to address the identification of applicable general safety and performance requirements and exploration of options to address those requirements;

Article 5(2)

A device shall meet the general safety and performance requirements set out in Annex I which apply to it, taking into account its intended purpose.

GSPR Checklist

Annex I

Applicable GSPRs are relevant regarding the device.

Annex I, Annex II(4)

The documentation shall contain information for the demonstration of conformity with the general safety and performance requirements set out in Annex I that are applicable to the device taking into account its intended purpose, and shall include a justification, validation and verification of the solutions adopted to meet those requirements. The demonstration of conformity shall include:

Annex I, Annex II(4a)

• the general safety and performance requirements that apply to the device and an explanation as to why others do not apply;

Annex I, Annex II(4b)

• the method or methods used to demonstrate conformity with each applicable general safety and performance requirement;

Annex I, Annex II(4c), Article 8, Article 9

• the harmonised standards, CS or other solutions applied; and

Annex I, Annex II(4d)

• the precise identity of the controlled documents offering evidence of conformity with each harmonised standard, CS or other method applied to demonstrate conformity with the general safety and performance requirements. The information referred to under this point shall incorporate a cross-reference to the location of such evidence within the full technical documentation and, if applicable, the summary technical documentation.

Description:

QMS procedure

Article 10(2), 10(9e)

Manufacturers shall establish, document, implement and maintain a system for risk management as described in Section 3 of Annex I.

Note: current harmonized EN ISO 14971 is used.

Risk Management File

Annex II(5)

The documentation shall contain information on:

Annex II(5a)

• the benefit-risk analysis referred to in Sections 1 and 8 of Annex I, and

Annex II(5b)

• the solutions adopted and the results of the risk management referred to in Section 3 of Annex I.

Description:

Article 6

Distance sales

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Claims

Article 7

In the labelling, instructions for use, making available, putting into service and advertising of devices, it shall be prohibited to use text, names, trade marks, pictures and figurative or other signs that may mislead the user or the patient with regard to the device’s intended purpose, safety and performance by:

1. ascribing functions and properties to the device which the device does not have;
2. creating a false impression regarding treatment or diagnosis, functions or properties which the device does not have;
3. failing to inform the user or the patient of a likely risk associated with the use of the device in line with its intended purpose;
4. suggesting uses for the device other than those stated to form part of the intended purpose for which the conformity assessment was carried out.

Translation

Article 10(11)

Manufacturers shall ensure that the device is accompanied by the information set out in Section 23 of Annex I in an official Union language(s) determined by the Member State in which the device is made available to the user or patient. The particulars on the label shall be indelible, easily legible and clearly comprehensible to the intended user or patient.

Trade show

Article 21(3)

At trade fairs, exhibitions, demonstrations or similar events, Member States shall not create obstacles to the showing of devices which do not comply with this Regulation, provided a visible sign clearly indicates that such devices are intended for presentation or demonstration purposes only and cannot be made available until they have been brought into compliance with this Regulation.

SSCP

Article 32(1)

The manufacturer shall mention on the label or instructions for use where the summary is available.

IFU

Annex I(23)

IFU complies with applicable requirements from Annex I.23

Labels

Annex I(23)

Labels comply with applicable requirements from Annex I.23

Description:

Article 18(1)

The manufacturer of an implantable device shall provide together with the device the following:

Article 18(1a)

• information allowing the identification of the device, including the device name, serial number, lot number, the UDI, the device model, as well as the name, address and the website of the manufacturer;

Article 18(1b)

• any warnings, precautions or measures to be taken by the patient or a healthcare professional with regard to reciprocal interference with reasonably foreseeable external influences, medical examinations or environmental conditions;

Article 18(1c)

• any information about the expected lifetime of the device and any necessary follow-up;

Article 18(1d)

• any other information to ensure safe use of the device by the patient, including the information in point (u) of Section 23.4 of Annex I.

Article 18(1), Article 10(10)

The information referred to in the first subparagraph shall be provided, for the purpose of making it available to the particular patient who has been implanted with the device, by any means that allow rapid access to that information and shall be stated in the language(s) determined by the concerned Member State. The information shall be written in a way that is readily understood by a lay person and shall be updated where appropriate. Updates of the information shall be made available to the patient via the website mentioned in point (a) of the first subparagraph.

Article 18(1)

In addition, the manufacturer shall provide the information referred to in point (a) of the first subparagraph on an implant card delivered with the device.

Article 18(2)

Member States shall require health institutions to make the information referred to in paragraph 1 available, by any means that allow rapid access to that information, to any patients who have been implanted with the device, together with the implant card, which shall bear their identity.

Article 18(3)

The following implants shall be exempted from the obligations laid down in this Article: sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors. The Commission is empowered to adopt delegated acts in accordance with Article 115 to amend this list by adding other types of implants to it or by removing implants therefrom.

Description:

Clinical evaluation procedure

Articles 5(3) and 10(3)

Manufacturers shall conduct a clinical evaluation in accordance with the requirements set out in Article 61 and Annex XIV, including a PMCF.

Demonstration of conformity with the general safety and performance requirements shall include a clinical evaluation in accordance with Article 61.

Article 10(9f)

QMS requirements are in place for the clinical evaluation in accordance with Article 61 and Annex XIV

Article 61(3)

A clinical evaluation shall follow a defined and methodologically sound procedure based on the following:

1. a critical evaluation of the relevant scientific literature currently available relating to the safety, performance, design characteristics and intended purpose of the device, where the following conditions are satisfied:
   • it is demonstrated that the device subject to clinical evaluation for the intended purpose is equivalent to the device to which the data relate, in accordance with Section 3 of Annex XIV, and
   • the data adequately demonstrate compliance with the relevant general safety and performance requirements;
2. a critical evaluation of the results of all available clinical investigations, taking duly into consideration whether the investigations were performed under Articles 62 to 80, any acts adopted pursuant to Article 81, and Annex XV; and
3. a consideration of currently available alternative treatment options for that purpose, if any.

Generalities

Article 61(1)

GSPR

Confirmation of conformity with relevant general safety and performance requirements set out in Annex I under the normal conditions of the intended use of the device, and the evaluation of the undesirable side-effects and of the acceptability of the benefit-risk- ratio referred to in Sections 1 and 8 of Annex I, shall be based on clinical data providing sufficient clinical evidence, including where applicable relevant data as referred to in Annex III.

Article 61(1)

Level of evidence

The manufacturer shall specify and justify the level of clinical evidence necessary to demonstrate conformity with the relevant general safety and performance requirements. That level of clinical evidence shall be appropriate in view of the characteristics of the device and its intended purpose.

Article 61(4)

Clinical investigation

In the case of implantable devices and class III devices, clinical investigations shall be performed, except if:

• the device has been designed by modifications of a device already marketed by the same manufacturer,
• the modified device has been demonstrated by the manufacturer to be equivalent to the marketed device, in accordance with Section 3 of Annex XIV and this demonstration has been endorsed by the notified body, and
• the clinical evaluation of the marketed device is sufficient to demonstrate conformity of the modified device with the relevant safety and performance requirements.

In this case, the notified body shall check that the PMCF plan is appropriate and includes post market studies to demonstrate the safety and performance of the device.

In addition, clinical investigations need not be performed in the cases referred to in paragraph 6.

Article 61(6),(7),(8)

The requirement to perform clinical investigations pursuant to paragraph 4 shall not apply to implantable devices and class III devices:

1. which have been lawfully placed on the market or put into service in accordance with Directive 90/385/EEC or Directive 93/42/EEC and for which the clinical evaluation:
   • is based on sufficient clinical data, and
   • is in compliance with the relevant product-specific CS for the clinical evaluation of that kind of device, where such a CS is available; or
2. that are sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips or connectors for which the clinical evaluation is based on sufficient clinical data and is in compliance with the relevant product-specific CS, where such a CS is available.

Cases in which paragraph 4 is not applied by virtue of paragraph 6 shall be justified in the clinical evaluation report by the manufacturer

Note: Where justified in view of well-established technologies, similar to those used in the exempted devices listed in point (b) of paragraph 6 of this Article, being used in other devices, or where justified in order to protect the health and safety of patients, users or other persons or other aspects of public health, the Commission is empowered to adopt delegated acts in accordance with Article 115 to amend the list of exempted devices referred to in the second subparagraph of Article 52(4) and in point (b) of paragraph 6 of this Article, by adding other types of implantable or class III devices to that list or removing devices therefrom.

Article 61(5)

Equivalent devices

A manufacturer of a device demonstrated to be equivalent to an already marketed device not manufactured by him, may also rely on paragraph 4 in order not to perform a clinical investigation provided that the following conditions are fulfilled in addition to what is required in that paragraph:

• the two manufacturers have a contract in place that explicitly allows the manufacturer of the second device full access to the technical documentation on an ongoing basis, and
• the original clinical evaluation has been performed in compliance with the requirements of this Regulation,

and the manufacturer of the second device provides clear evidence thereof to the notified body.

Article 61(10)

When non clinical data are required

Without prejudice to paragraph 4, where the demonstration of conformity with general safety and performance requirements based on clinical data is not deemed appropriate, adequate justification for any such exception shall be given based on the results of the manufacturer’s risk management and on consideration of the specifics of the interaction between the device and the human body, the clinical performance intended and the claims of the manufacturer. In such a case, the manufacturer shall duly substantiate in the technical documentation referred to in Annex II why it considers a demonstration of conformity with general safety and performance requirements that is based on the results of non-clinical testing methods alone, including performance evaluation, bench testing and pre-clinical evaluation, to be adequate.

Article 61(9)

Annex XVI devices

In the case of the products without an intended medical purpose listed in Annex XVI, the requirement to demonstrate a clinical benefit in accordance with this Chapter and Annexes XIV and XV shall be understood as a requirement to demonstrate the performance of the device. Clinical evaluations of those products shall be based on relevant data concerning safety, including data from post-market surveillance, PMCF, and, where applicable, specific clinical investigation. Clinical investigations shall be performed for those products unless reliance on existing clinical data from an analogous medical device is duly justified.

Article 61(1)

Records

To that end, manufacturers shall plan, conduct and document a clinical evaluation in accordance with this Article and Part A of Annex XIV.

Clinical evaluation consultation procedure

Article 61(2)

For all class III devices and for the class IIb devices referred to in point (b) of Article 54(1), the manufacturer may, prior to its clinical evaluation and/or investigation, consult an expert panel as referred to in Article 106, with the aim of reviewing the manufacturer’s intended clinical development strategy and proposals for clinical investigation. The manufacturer shall give due consideration to the views expressed by the expert panel. Such consideration shall be documented in the clinical evaluation report referred to in paragraph 12 of this Article.

The manufacturer may not invoke any rights to the views expressed by the expert panel with regard to any future conformity assessment procedure.

CEP

Article 61(11)

The clinical evaluation and its documentation shall be updated throughout the life cycle of the device concerned with clinical data obtained from the implementation of the manufacturer’s PMCF plan in accordance with Part B of Annex XIV and the post-market surveillance plan referred to in Article 84.

Annex XIV(1)

A clinical evaluation plan shall include at least:

Annex XIV(1a)

• an identification of the general safety and performance requirements that require support from relevant clinical data;
• a specification of the intended purpose of the device;
• a clear specification of intended target groups with clear indications and contra-indications;
• a detailed description of intended clinical benefits to patients with relevant and specified clinical outcome parameters;
• a specification of methods to be used for examination of qualitative and quantitative aspects of clinical safety with clear reference to the determination of residual risks and side-effects;
• an indicative list and specification of parameters to be used to determine, based on the state of the art in medicine, the acceptability of the benefit-risk ratio for the various indications and for the intended purpose or purposes of the device;
• an indication how benefit-risk issues relating to specific components such as use of pharmaceutical, non-viable animal or human tissues, are to be addressed; and
• a clinical development plan indicating progression from exploratory investigations, such as first-in-man studies, feasibility and pilot studies, to confirmatory investigations, such as pivotal clinical investigations, and a PMCF as referred to in Part B of this Annex with an indication of milestones and a description of potential acceptance criteria;

CER

Article 61(11)

The clinical evaluation and its documentation shall be updated throughout the life cycle of the device concerned with clinical data obtained from the implementation of the manufacturer’s PMCF plan in accordance with Part B of Annex XIV and the post-market surveillance plan referred to in Article 84.

Article 61(12)

The clinical evaluation, its results and the clinical evidence derived from it shall be documented in a clinical evaluation report as referred to in Section 4 of Annex XIV, which, except for custom-made devices, shall be part of the technical documentation referred to in Annex II relating to the device concerned.

Annex XIV(1)

A clinical evaluation report shall include at least:

Annex XIV(1b)

• identify available clinical data relevant to the device and its intended purpose and any gaps in clinical evidence through a systematic scientific literature review;

Annex XIV(1c)

• appraise all relevant clinical data by evaluating their suitability for establishing the safety and performance of the device;

Annex XIV(1d)

• generate, through properly designed clinical investigations in accordance with the clinical development plan, any new or additional clinical data necessary to address outstanding issues; and

Annex XIV(1e)

• analyse all relevant clinical data in order to reach conclusions about the safety and clinical performance of the device including its clinical benefits.

Annex XIV(2)

The clinical evaluation shall be thorough and objective, and take into account both favourable and unfavourable data. Its depth and extent shall be proportionate and appropriate to the nature, classification, intended purpose and risks of the device in question, as well as to the manufacturer’s claims in respect of the device

Annex XIV(3)

A clinical evaluation may be based on clinical data relating to a device for which equivalence to the device in question can be demonstrated. The following technical, biological and clinical characteristics shall be taken into consideration for the demonstration of equivalence:

• Technical: the device is of similar design; is used under similar conditions of use; has similar specifications and properties including physicochemical properties such as intensity of energy, tensile strength, viscosity, surface characteristics, wavelength and software algorithms; uses similar deployment methods, where relevant; has similar principles of operation and critical performance requirements;
• Biological: the device uses the same materials or substances in contact with the same human tissues or body fluids for a similar kind and duration of contact and similar release characteristics of substances, including degradation products and leachables;
• Clinical: the device is used for the same clinical condition or purpose, including similar severity and stage of disease, at the same site in the body, in a similar population, including as regards age, anatomy and physiology; has the same kind of user; has similar relevant critical performance in view of the expected clinical effect for a specific intended purpose.

The characteristics listed in the first paragraph shall be similar to the extent that there would be no clinically significant difference in the safety and clinical performance of the device. Considerations of equivalence shall be based on proper scientific justification. It shall be clearly demonstrated that manufacturers have sufficient levels of access to the data relating to devices with which they are claiming equivalence in order to justify their claims of equivalence.

Annex XIV(4)

The results of the clinical evaluation and the clinical evidence on which it is based shall be documented in a clinical evaluation report which shall support the assessment of the conformity of the device.

The clinical evidence together with non-clinical data generated from non-clinical testing methods and other relevant documentation shall allow the manufacturer to demonstrate conformity with the general safety and performance requirements and shall be part of the technical documentation for the device in question.

Both favourable and unfavourable data considered in the clinical evaluation shall be included in the technical documentation.

Description:

Transition requirements

Article 120(11)

Clinical investigations which have started to be conducted in accordance with Article 10 of Directive 90/385/EEC or Article 15 of Directive 93/42/EEC prior to ►M1 26 May 2021 ◄ may continue to be conducted. As of ►M1 26 May 2021 ◄ , however, the reporting of serious adverse events and device deficiencies shall be carried out in accordance with this Regulation.

Clinical investigation

Article 62(2), (4c)

Sponsor

The sponsor, or its legal representative or a contact person pursuant to paragraph 2, is established in the Union;

Note: Where the sponsor of a clinical investigation is not established in the Union, that sponsor shall ensure that a natural or legal person is established in the Union as its legal representative. Such legal representative shall be responsible for ensuring compliance with the sponsor’s obligations pursuant to this Regulation, and shall be the addressee for all communications with the sponsor provided for in this Regulation. Any communication with that legal representative shall be deemed to be a communication with the sponsor.

Note: Member States may choose not to apply the first subparagraph to clinical investigations to be conducted solely on their territory, or on their territory and the territory of a third country, provided that they ensure that the sponsor establishes at least a contact person on their territory in respect of that clinical investigation who shall be the addressee for all communications with the sponsor provided for in this Regulation.

Annex XV(III)

The sponsor meets the general obligations:

Annex XV(III.1)

The sponsor shall undertake to keep available for the competent national authorities any documentation necessary to provide evidence for the documentation referred to in Chapter II of this Annex. If the sponsor is not the natural or legal person responsible for the manufacture of the investigational device, that obligation may be fulfilled by that person on behalf of the sponsor.

Annex XV(III.2)

The Sponsor shall have an agreement in place to ensure that any serious adverse events or any other event as referred to in Article 80(2) are reported by the investigator or investigators to the sponsor in a timely manner.

Annex XV(III.3)

The documentation mentioned in this Annex shall be kept for a period of at least 10 years after the clinical investigation with the device in question has ended, or, in the event that the device is subsequently placed on the market, at least 10 years after the last device has been placed on the market. In the case of implantable devices, the period shall be at least 15 years.

Annex XV(III.4)

The Sponsor shall appoint a monitor that is independent from the investigational site to ensure that the investigation is conducted in accordance with the CIP, the principles of good clinical practice and this Regulation.

Annex XV(III.5)

The Sponsor shall complete the follow-up of investigation subjects

Annex XV(III.6)

The Sponsor shall provide evidence that the investigation is being conducted in line with good clinical practice, for instance through internal or external inspection.

Articles 62(3), (4d), (4h), 64, 65, 66, 67 and 68

Clinical integrity

Vulnerable populations and subjects are appropriately protected in accordance with Articles 64 to 68.

The rights of the subject to physical and mental integrity, to privacy and to the protection of the data concerning him or her in accordance with Directive 95/46/EC are safeguarded;

Note: Clinical investigations shall be designed and conducted in such a way that the rights, safety, dignity and well-being of the subjects participating in a clinical investigation are protected and prevail over all other interests and the clinical data generated are scientifically valid, reliable and robust.

Article 62(3), (4b)

Ethical review

Clinical investigations shall be subject to scientific and ethical review.

• An ethics committee, set up in accordance with national law, has not issued a negative opinion in relation to the clinical investigation, which is valid for that entire Member State under its national law;

Article 62(4a)

Approval by Member States

The clinical investigation is the subject of an authorisation by the Member State(s) in which the clinical investigation is to be conducted, in accordance with this Regulation, unless otherwise stated

Articles 62(4f), 63

Informed consent

The subject or, where the subject is not able to give informed consent, his or her legally designated representative has given informed consent in accordance with Article 63;

Article 62(6)

Investigator

The investigator shall be a person exercising a profession which is recognised in the Member State concerned as qualifying for the role of investigator on account of having the necessary scientific knowledge and experience in patient care. Other personnel involved in conducting a clinical investigation shall be suitably qualified, by education, training or experience in the relevant medical field and in clinical research methodology, to perform their tasks.

Article 70(1), Annex XV(II.1)

Application for a clinical investigation

The sponsor of a clinical investigation shall submit an application to the Member State(s) in which the clinical investigation is to be conducted (referred to for the purposes of this Article as ‘Member State concerned’) accompanied by the documentation referred to in Chapter II of Annex XV.

Article 70(1)

The application shall be submitted by means of the electronic system referred to in Article 73, which shall generate a Union-wide unique single identification number for the clinical investigation, which shall be used for all relevant communication in relation to that clinical investigation.

Article 70(2)

Within one week of any change occurring in relation to the documentation referred to in Chapter II of Annex XV, the sponsor shall update the relevant data in the electronic system referred to in Article 73 and make that change to the documentation clearly identifiable. The Member State concerned shall be notified of the update by means of that electronic system.

Annex XV(II.2)

Investigator brochure

The investigator’s brochure (IB) shall contain the clinical and non-clinical information on the investigational device that is relevant for the investigation and available at the time of application. Any updates to the IB or other relevant information that is newly available shall be brought to the attention of the investigators in a timely manner.

Article 72(1)

Clinical investigation plan

The sponsor and the investigator shall ensure that the clinical investigation is conducted in accordance with the approved clinical investigation plan.

Annex XIV(II.3)

The clinical investigation plan (CIP) shall set out the rationale, objectives, design methodology, monitoring, conduct, record-keeping and the method of analysis for the clinical investigation. It shall contain in particular the information as laid down in this Annex. If part of this information is submitted in a separate document, it shall be referenced in the CIP.

Article 70(7)

Start of the clinical investigation

The sponsor may start the clinical investigation in the following circumstances:

• • • • 1. in the case of investigational class I devices or in the case of non-invasive class IIa and class IIb devices, unless otherwise stated by national law, immediately after the validation date of the application pursuant to paragraph 5, and provided that a negative opinion which is valid for the entire Member State, under national law, has not been issued by an ethics committee in the Member State concerned in respect of the clinical investigation;
        2. in the case of investigational devices, other than those referred to in point (a), as soon as the Member State concerned has notified the sponsor of its authorisation, and provided that a negative opinion which is valid for the entire Member State, under national law, has not been issued by an ethics committee in the Member State concerned in respect of the clinical investigation. The Member State shall notify the sponsor of the authorisation within 45 days of the validation date referred to in paragraph 5. The Member State may extend this period by a further 20 days for the purpose of consulting with experts.

Article 75(1)

Substantial modifications to clinical investigations

If a sponsor intends to introduce modifications to a clinical investigation that are likely to have a substantial impact on the safety, health or rights of the subjects or on the robustness or reliability of the clinical data generated by the investigation, it shall notify, within one week, by means of the electronic system referred to in Article 73 the Member State(s) in which the clinical investigation is being or is to be conducted of the reasons for and the nature of those modifications. The sponsor shall include an updated version of the relevant documentation referred to in Chapter II of Annex XV as part of the notification. Changes to the relevant documentation shall be clearly identifiable.

Article 75(3), (4)

The sponsor may implement the modifications referred to in paragraph 1 at the earliest 38 days after the notification referred to in that paragraph, unless:

• • • • 1. the Member State in which the clinical investigation is being or is to be conducted has notified the sponsor of its refusal based on the grounds referred to in Article 71(4) or on considerations of public health, subject and user safety or health, of public policy, or
        2. an ethics committee in that Member State has issued a negative opinion in relation to the substantial modification to the clinical investigation, which, in accordance with national law, is valid for that entire Member State.

Note: The Member State(s) concerned may extend the period referred to in paragraph 3 by a further seven days, for the purpose of consulting with experts.

Article 77(1)

End of a clinical investigation or in the event of a temporary halt or early termination

If the sponsor has temporarily halted a clinical investigation or has terminated a clinical investigation early, it shall inform within 15 days the Member State in which that clinical investigation has been temporarily halted or terminated early, through the electronic system referred to in Article 73, of the temporary halt or early termination, providing a justification. In the event that the sponsor has temporarily halted or terminated early the clinical investigation on safety grounds, it shall inform all Member States in which that clinical investigation is being conducted thereof within 24 hours.

Article 77(2)

The end of a clinical investigation shall be deemed to coincide with the last visit of the last subject unless another point in time for such end is set out in the clinical investigation plan.

Article 77(3), (4)

The sponsor shall notify each Member State in which a clinical investigation was being conducted of the end of that clinical investigation in that Member State. That notification shall be made within 15 days of the end of the clinical investigation in relation to that Member State.

If an investigation is conducted in more than one Member State, the sponsor shall notify all Member States in which that clinical investigation was conducted of the end of the clinical investigation in all Member States. That notification shall be made within 15 days of that end of the clinical investigation.

Article 77(5)

Clinical investigation report

Irrespective of the outcome of the clinical investigation, within one year of the end of the clinical investigation or within three months of the early termination or temporary halt, the sponsor shall submit to the Member States in which a clinical investigation was conducted a clinical investigation report as referred to in Section 2.8 of Chapter I and Section 7 of Chapter III of Annex XV.

Where, for scientific reasons, it is not possible to submit the clinical investigation report within one year of the end of the investigation, it shall be submitted as soon as it is available. In such case, the clinical investigation plan referred to in Section 3 of Chapter II of Annex XV shall specify when the results of the clinical investigation are going to be available, together with a justification.

Annex XV(III.7)

The Sponsor shall prepare a clinical investigation report which includes at least the following:

Annex XV(III.7)

• Cover/introductory page or pages indicating the title of the investigation, the investigational device, the single identification number, the CIP number and the details with signatures of the coordinating investigators and the principal investigators from each investigational site.

Annex XV(III.7)

• Details of the author and date of the report.

Annex XV(III.7)

• A summary of the investigation covering the title, purpose of the investigation, description of the investigation, investigational design and methods used, the results of the investigation and conclusion of the investigation. The completion date of the investigation, and in particular details of early termination, temporary halts or suspensions of investigations.

Annex XV(III.7)

• Investigational device description, in particular clearly defined intended purpose.

Annex XV(III.7)

• A summary of the clinical investigation plan covering objectives, design, ethical aspects, monitoring and quality measures, selection criteria, target patient populations, sample size, treatment schedules, follow-up duration, concomitant treatments, statistical plan, including hypothesis, sample size calculation and analysis methods, as well as a justification.

Annex XV(III.7)

• Results of the clinical investigation covering, with rationale and justification, subject demographics, analysis of results related to chosen endpoints, details of subgroup analysis, as well as compliance with the CIP, and covering follow-up of missing data and of patients withdrawing from the clinical investigation, or lost to follow-up.

Annex XV(III.7)

• Summary of serious adverse events, adverse device effects, device deficiencies and any relevant corrective actions.

Annex XV(III.7)

• Discussion and overall conclusions covering safety and performance results, assessment of risks and clinical benefits, discussion of clinical relevance in accordance with clinical state of the art, any specific precautions for specific patient populations, implications for the investigational device, limitations of the investigation.

Article 80(1)

Adverse event

The sponsor shall fully record all of the following:

1. any adverse event of a type identified in the clinical investigation plan as being critical to the evaluation of the results of that clinical investigation;
2. any serious adverse event;
3. any device deficiency that might have led to a serious adverse event if appropriate action had not been taken, intervention had not occurred, or circumstances had been less fortunate;
4. any new findings in relation to any event referred to in points (a) to (c).

Article 80(2)

Adverse event reporting

The sponsor shall report, without delay to all Member States in which the clinical investigation is being conducted, all of the following by means of the electronic system referred to in Article 73:

1. any serious adverse event that has a causal relationship with the investigational device, the comparator or the investigation procedure or where such causal relationship is reasonably possible;
2. any device deficiency that might have led to a serious adverse event if appropriate action had not been taken, intervention had not occurred, or circumstances had been less fortunate;
3. any new findings in relation to any event referred to in points (a) and (b).

The period for reporting shall take account of the severity of the event. Where necessary to ensure timely reporting, the sponsor may submit an initial report that is incomplete followed up by a complete report.

Article 80(3)

The sponsor shall also report to the Member States in which the clinical investigation is being conducted any event referred to in paragraph 2 of this Article that occurred in third countries in which a clinical investigation is performed under the same clinical investigation plan as the one applying to a clinical investigation covered by this Regulation by means of the electronic system referred to in Article 73.

Article 80(4)

In the case of a clinical investigation for which the sponsor has used the single application referred to in Article 78, the sponsor shall report any event as referred to in paragraph 2 of this Article by means of the electronic system referred to in Article 73. Upon receipt, this report shall be transmitted electronically to all Member States in which the clinical investigation is being conducted.

Article 74(1)

PMCF investigation

Where a clinical investigation is to be conducted to further assess, within the scope of its intended purpose, a device which already bears the CE marking in accordance with Article 20(1), (‘PMCF investigation’), and where the investigation would involve submitting subjects to procedures additional to those performed under the normal conditions of use of the device and those additional procedures are invasive or burdensome, the sponsor shall notify the Member States concerned at least 30 days prior to its commencement by means of the electronic system referred to in Article 73. The sponsor shall include the documentation referred to in Chapter II of Annex XV as part of the notification. Points (b) to (k) and (m) ►C1 of Article 62(4), Articles 75, 76 and 77, and Article 80(5) and (6), and the relevant provisions ◄ of Annex XV shall apply to PMCF investigations.

Article 74(2)

Where a clinical investigation is to be conducted to assess, outside the scope of its intended purpose, a device which already bears the CE marking in accordance with Article 20(1), Articles 62 to 81 shall apply.

Article 80(5)

The provisions on vigilance laid down in Articles 87 to 90 and in the acts adopted pursuant to Article 91 shall apply instead of this Article.

Article 82

Other clinical investigations

Clinical investigations, not performed pursuant to any of the purposes listed in Article 62(1), shall comply with the provisions of Article 62 (2) and (3), points (b), (c), (d), (f), (h), and (l) of Article 62(4) and Article 62(6).

Description:

Translation

Article 10(11)

Manufacturers shall ensure that the device is accompanied by the information set out in Section 23 of Annex I in an official Union language(s) determined by the Member State in which the device is made available to the user or patient. The particulars on the label shall be indelible, easily legible and clearly comprehensible to the intended user or patient.

Article 32(1)

For implantable devices and for class III devices, other than custom-made or investigational devices, the manufacturer shall draw up a summary of safety and clinical performance.

Article 32(1)

The summary of safety and clinical performance shall be written in a way that is clear to the intended user and, if relevant, to the patient and shall be made available to the public via Eudamed.

Article 32(1)

The draft of the summary of safety and clinical performance shall be part of the documentation to be submitted to the notified body involved in the conformity assessment pursuant to Article 52 and shall be validated by that body.

Note: After its validation, the notified body shall upload the summary to Eudamed.

Article 32(2)

The summary of safety and clinical performance shall include at least the following aspects:

Article 32(2a)

• the identification of the device and the manufacturer, including the Basic UDI-DI and, if already issued, the SRN;

Article 32(2b)

• the intended purpose of the device and any indications, contraindications and target populations;

Article 32(2c)

• a description of the device, including a reference to previous generation(s) or variants if such exist, and a description of the differences, as well as, where relevant, a description of any accessories, other devices and products, which are intended to be used in combination with the device;

Article 32(2d)

• possible diagnostic or therapeutic alternatives

Article 32(2e)

• reference to any harmonised standards and CS applied;

Article 32(2f)

• the summary of clinical evaluation as referred to in Annex XIV, and relevant information on post-market clinical follow-up

Article 32(2g)

• suggested profile and training for users;

Article 32(2h)

• information on any residual risks and any undesirable effects, warnings and precautions.

Update

Article 61(11)

For class III devices and implantable devices, the PMCF evaluation report and, if indicated, the summary of safety and clinical performance referred to in Article 32 shall be updated at least annually with such data.

Description:

DoC

Article 10(6)

Where compliance with the applicable requirements has been demonstrated following the applicable conformity assessment procedure, manufacturers of devices, other than custom-made or investigational devices, shall draw up an EU declaration of conformity in accordance with Article 19, and affix the CE marking of conformity in accordance with Article 20.

Article 19(1)

The EU declaration of conformity shall state that the requirements specified in this Regulation have been fulfilled in relation to the device that is covered. The manufacturer shall continuously update the EU declaration of conformity. The EU declaration of conformity shall, as a minimum, contain the information set out in Annex IV and shall be translated into an official Union language or languages required by the Member State(s) in which the device is made available.

Article 19(2)

Where, concerning aspects not covered by this Regulation, devices are subject to other Union legislation which also requires an EU declaration of conformity by the manufacturer that fulfilment of the requirements of that legislation has been demonstrated, a single EU declaration of conformity shall be drawn up in respect of all Union acts applicable to the device. The declaration shall contain all the information required for identification of the Union legislation to which the declaration relates.

Article 19(3)

By drawing up the EU declaration of conformity, the manufacturer shall assume responsibility for compliance with the requirements of this Regulation and all other Union legislation applicable to the device.

Article 27(6)

The Basic UDI-DI, as defined in Part C of Annex VI, of the device shall appear on the EU declaration of conformity referred to in Article 19

Annex IV

The EU declaration of conformity shall contain all of the following information:

• Name, registered trade name or registered trade mark and, if already issued, SRN as referred to in Article 31 of the manufacturer, and, if applicable, its authorised representative, and the address of their registered place of business where they can be contacted and their location be established;
• A statement that the EU declaration of conformity is issued under the sole responsibility of the manufacturer;
• The Basic UDI-DI as referred to in Part C of Annex VI;
• Product and trade name, product code, catalogue number or other unambiguous reference allowing identification and traceability of the device covered by the EU declaration of conformity, such as a photograph, where appropriate, as well as its intended purpose. Except for the product or trade name, the information allowing identification and traceability may be provided by the Basic UDI-DI referred to in point 3;
• Risk class of the device in accordance with the rules set out in Annex VIII;
• A statement that the device that is covered by the present declaration is in conformity with this Regulation and, if applicable, with any other relevant Union legislation that provides for the issuing of an EU declaration of conformity;
• 7.References to any CS used and in relation to which conformity is declared;
• Where applicable, the name and identification number of the notified body, a description of the conformity assessment procedure performed and identification of the certificate or certificates issued;
• Where applicable, additional information;
• Place and date of issue of the declaration, name and function of the person who signed it as well as an indication for, and on behalf of whom, that person signed, signature.

CE mark

Article 20(1)

Devices, other than custom-made or investigational devices, considered to be in conformity with the requirements of this Regulation shall bear the CE marking of conformity, as presented in Annex V.

Article 20(2)

The CE marking shall be subject to the general principles set out in Article 30 of Regulation (EC) No 765/2008.

Article 20(3)

The CE marking shall be affixed visibly, legibly and indelibly to the device or its sterile packaging. Where such affixing is not possible or not warranted on account of the nature of the device, the CE marking shall be affixed to the packaging. The CE marking shall also appear in any instructions for use and on any sales packaging.

Article 20(4)

The CE marking shall be affixed before the device is placed on the market. It may be followed by a pictogram or any other mark indicating a special risk or use.

Article 20(5)

Where applicable, the CE marking shall be followed by the identification number of the notified body responsible for the conformity assessment procedures set out in Article 52. The identification number shall also be indicated in any promotional material which mentions that a device fulfils the requirements for CE marking.

Article 20(6)

Where devices are subject to other Union legislation which also provides for the affixing of the CE marking, the CE marking shall indicate that the devices also fulfil the requirements of that other legislation.

Annex V(3)

The various components of the CE marking shall have substantially the same vertical dimension, which may not be less than 5 mm. This minimum dimension may be waived for small-scale devices.

Description:

PMS procedure

Articles 10(9i), 10(10)

Manufacturers of devices shall implement and keep up to date the post-market surveillance system in accordance with Article 83.

The QMS need to address the setting-up, implementation and maintenance of a post-market surveillance system, in accordance with Article 83;

PMS procedure:

Article 83(1)

For each device, manufacturers shall plan, establish, document, implement, maintain and update a post-market surveillance system in a manner that is proportionate to the risk class and appropriate for the type of device. That system shall be an integral part of the manufacturer’s quality management system referred to in Article 10(9).

Article 83(2)

The post-market surveillance system shall be suited to actively and systematically gathering, recording and analysing relevant data on the quality, performance and safety of a device throughout its entire lifetime, and to drawing the necessary conclusions and to determining, implementing and monitoring any preventive and corrective actions.

Article 83(3)

Data gathered by the manufacturer’s post-market surveillance system shall in particular be used:

Article 83(3a)

• to update the benefit-risk determination and to improve the risk management as referred to in Chapter I of Annex I;

Article 83(3b)

• to update the design and manufacturing information, the instructions for use and the labelling;

Article 83(3c)

• to update the clinical evaluation;

Article 83(3d)

• to update the summary of safety and clinical performance referred to in Article 32;

Article 83(3e)

• for the identification of needs for preventive, corrective or field safety corrective action;

Article 83(3f)

• for the identification of options to improve the usability, performance and safety of the device

Article 83(3g)

• when relevant, to contribute to the post-market surveillance of other devices; and

Article 83(3h)

• to detect and report trends in accordance with Article 88

Article 83(3)

If, in the course of the post-market surveillance, a need for preventive or corrective action or both is identified, the manufacturer shall implement the appropriate measures and inform the competent authorities concerned and, where applicable, the notified body. Where a serious incident is identified or a field safety corrective action is implemented, it shall be reported in accordance with Article 87.

PMS plan

Article 84

The post-market surveillance system referred to in Article 83 shall be based on a post-market surveillance plan, the requirements for which are set out in ►C2 Section 1 of Annex III. ◄ For devices other than custom-made devices, the post-market surveillance plan shall be part of the technical documentation specified in Annex II.

Annex III(1a)

The post-market surveillance plan shall address the collection and utilization of available information, in particular:

• information concerning serious incidents, including information from PSURs, and field safety corrective actions;
• records referring to non-serious incidents and data on any undesirable side-effects;
• information from trend reporting;
• relevant specialist or technical literature, databases and/or registers;
• information, including feedbacks and complaints, provided by users, distributors and importers; and
• publicly available information about similar medical devices.

Annex III(1b)

The post-market surveillance plan shall cover at least:

• a proactive and systematic process to collect any information referred to in point (a). The process shall allow a correct characterisation of the performance of the devices and shall also allow a comparison to be made between the device and similar products available on the market;
• effective and appropriate methods and processes to assess the collected data;
• suitable indicators and threshold values that shall be used in the continuous reassessment of the benefit-risk analysis and of the risk management as referred to in Section 3 of Annex I;
• effective and appropriate methods and tools to investigate complaints and analyse market-related experience collected in the field;
• methods and protocols to manage the incidents subject to the trend report as provided for in Article 88, including the methods and protocols to be used to establish any statistically significant increase in the frequency or severity of incidents as well as the observation period;
• methods and protocols to communicate effectively with competent authorities, notified bodies, economic operators and users;
• reference to procedures to fulfil the manufacturers obligations laid down in Articles 83, 84 and 86;
• systematic procedures to identify and initiate appropriate measures including corrective actions;
• effective tools to trace and identify devices for which corrective actions might be necessary; and
• a PMCF plan as referred to in Part B of Annex XIV, or a justification as to why a PMCF is not applicable.

PMS report

Article 85, Annex III(2)

Manufacturers of class I devices shall prepare a post-market surveillance report summarising the results and conclusions of the analyses of the post-market surveillance data gathered as a result of the post-market surveillance plan referred to in Article 84 together with a rationale and description of any preventive and corrective actions taken. The report shall be updated when necessary and made available to the competent authority upon request.

PSUR

Article 86(1), Annex III(2)

Manufacturers of class IIa, class IIb and class III devices shall prepare a periodic safety update report (‘PSUR’) for each device and where relevant for each category or group of devices summarising the results and conclusions of the analyses of the post-market surveillance data gathered as a result of the post-market surveillance plan referred to in Article 84 together with a rationale and description of any preventive and corrective actions taken. Throughout the lifetime of the device concerned, that PSUR shall set out:

• • • • 1. the conclusions of the benefit-risk determination;
        2. the main findings of the PMCF; and
        3. the volume of sales of the device and an estimate evaluation of the size and other characteristics of the population using the device and, where practicable, the usage frequency of the device.

Article 86(1)

Manufacturers of class IIb and class III devices shall update the PSUR at least annually. That PSUR shall, except in the case of custom-made devices, be part of the technical documentation as specified in Annexes II and III.

Manufacturers of class IIa devices shall update the PSUR when necessary and at least every two years. That PSUR shall, except in the case of custom-made devices, be part of the technical documentation as specified in Annexes II and III.

Article 86(1)

For custom-made devices, the PSUR shall be part of the documentation referred to in Section 2 of Annex XIII.

Article 86(2)

For class III devices or implantable devices, manufacturers shall submit PSURs by means of the electronic system referred to in Article 92 to the notified body involved in the conformity assessment in accordance with Article 52. The notified body shall review the report and add its evaluation to that electronic system with details of any action taken. Such PSURs and the evaluation by the notified body shall be made available to competent authorities through that electronic system.

Article 86(2)

For devices other than those referred to in paragraph 2, manufacturers shall make PSURs available to the notified body involved in the conformity assessment and, upon request, to competent authorities.

Trends

Article 88(1)

The manufacturer shall specify how to manage the incidents referred to below and the methodology used for determining any statistically significant increase in the frequency or severity of such incidents, as well as the observation period, in the post-market surveillance plan referred to in Article 84.

Manufacturers shall report, by means of the electronic system referred to in Article 92, any statistically significant increase in the frequency or severity of incidents that are not serious incidents or that are expected undesirable side-effects that could have a significant impact on the benefit-risk analysis ►C2 referred to in Sections 1 and 8 of Annex I and which ◄ have led or may lead to risks to the health or safety of patients, users or other persons that are unacceptable when weighed against the intended benefits. The significant increase shall be established in comparison to the foreseeable frequency or severity of such incidents in respect of the device, or category or group of devices, in question during a specific period as specified in the technical documentation and product information.

Description:

Procedure

Article 10(9f)

clinical evaluation in accordance with Article 61 and Annex XIV, including PMCF

Article 61(11)

For class III devices and implantable devices, the PMCF evaluation report and, if indicated, the summary of safety and clinical performance referred to in Article 32 shall be updated at least annually with such data.

Annex XIV(5)

PMCF shall be understood to be a continuous process that updates the clinical evaluation referred to in Article 61 and Part A of this Annex and shall be addressed in the manufacturer’s post-market surveillance plan. When conducting PMCF, the manufacturer shall proactively collect and evaluate clinical data from the use in or on humans of a device which bears the CE marking and is placed on the market or put into service within its intended purpose as referred to in the relevant conformity assessment procedure, with the aim of confirming the safety and performance throughout the expected lifetime of the device, of ensuring the continued acceptability of identified risks and of detecting emerging risks on the basis of factual evidence.

PMCF Plan

Annex XIV(6)

PMCF shall be performed pursuant to a documented method laid down in a PMCF plan.

Annex XIV(6.1)

The PMCF plan shall specify the methods and procedures for proactively collecting and evaluating clinical data with the aim of:

1. confirming the safety and performance of the device throughout its expected lifetime,
2. identifying previously unknown side-effects and monitoring the identified side-effects and contraindications,
3. identifying and analysing emergent risks on the basis of factual evidence,
4. ensuring the continued acceptability of the benefit-risk ratio referred to in Sections 1 and 9 of Annex I, and
5. identifying possible systematic misuse or off-label use of the device, with a view to verifying that the intended purpose is correct.

Annex XIV(6.2)

The PMCF plan shall include at least:

Annex XIV(6.2a)

• the general methods and procedures of the PMCF to be applied, such as gathering of clinical experience gained, feedback from users, screening of scientific literature and of other sources of clinical data;

Annex XIV(6.2b)

• the specific methods and procedures of PMCF to be applied, such as evaluation of suitable registers or PMCF studies;

Annex XIV(6.2c)

• a rationale for the appropriateness of the methods and procedures referred to in points (a) and (b);

Annex XIV(6.2d)

• a reference to the relevant parts of the clinical evaluation report referred to in Section 4 and to the risk management referred to in Section 3 of Annex I;

Annex XIV(6.2e)

• the specific objectives to be addressed by the PMCF;

Annex XIV(6.2f)

• an evaluation of the clinical data relating to equivalent or similar devices;

Annex XIV(6.2g)

• reference to any relevant CS, harmonised standards when used by the manufacturer, and relevant guidance on PMCF; and

Annex XIV(6.2h)

• a detailed and adequately justified time schedule for PMCF activities (e.g. analysis of PMCF data and reporting) to be undertaken by the manufacturer.

PMCF Evaluation Report

Annex XIV(67)

The manufacturer shall analyse the findings of the PMCF and document the results in a PMCF evaluation report that shall be part of the clinical evaluation report and the technical documentation.

Annex XIV(8)

The conclusions of the PMCF evaluation report shall be taken into account for the clinical evaluation referred to in Article 61 and Part A of this Annex and in the risk management referred to in Section 3 of Annex I. If, through the PMCF, the need for preventive and/or corrective measures has been identified, the manufacturer shall implement them.

Description:

Article 10(9)

Manufacturers shall ensure that procedures are in place to keep series production in conformity with the requirements of this Regulation. Changes in device design or characteristics and changes in the harmonised standards or CS by reference to which the conformity of a device is declared shall be adequately taken into account in a timely manner. Manufacturers of devices, other than investigational devices, shall establish, document, implement, maintain, keep up to date and continually improve a quality management system that shall ensure compliance with this Regulation in the most effective manner and in a manner that is proportionate to the risk class and the type of device.

Article 10(9)

The quality management system shall cover all parts and elements of a manufacturer’s organisation dealing with the quality of processes, procedures and devices. It shall govern the structure, responsibilities, procedures, processes and management resources required to implement the principles and actions necessary to achieve compliance with the provisions of this Regulation.

–

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Article 10(9)

The quality management system shall address at least the following aspects:

Article 10(9c)

• responsibility of the management;

Article 10(9d)

• resource management, including selection and control of suppliers and sub-contractors;

Article 10(9g)

• product realisation, including planning, design, development, production and service provision;

Article 10(9j)

• handling communication with competent authorities, notified bodies, other economic operators, customers and/or other stakeholders;

Article 10(9l)

• management of corrective and preventive actions and verification of their effectiveness;

Article 10(9m)

• processes for monitoring and measurement of output, data analysis and product improvement

Description:

Article 25(1)

Distributors and importers shall co-operate with manufacturers or authorised representatives to achieve an appropriate level of traceability of devices.

Article 25(2)

Economic operators shall be able to identify the following to the competent authority, for the period referred to in Article 10(8):

Article 25(2a)

• any economic operator to whom they have directly supplied a device;

Article 25(2b)

• any economic operator who has directly supplied them with a device;

Article 25(2c)

• any health institution or healthcare professional to which they have directly supplied a device.

Article 27(8)

Economic operators shall store and keep, preferably by electronic means, the UDI of the devices which they have supplied or with which they have been supplied, if those devices belong to:

— class III implantable devices;

— the devices, categories or groups of devices determined by a measure referred to in point (a) of paragraph 11.

Description:

UDI Procedure

Article 27(1)

The Unique Device Identification system (‘UDI system’) described in Part C of Annex VI shall allow the identification and facilitate the traceability of devices, other than custom-made and investigational devices, and shall consist of the following:

Article 27(1a)

• production of a UDI that comprises the following:

Article 27(1a,i)

• • a UDI device identifier (‘UDI-DI’) specific to a manufacturer and a device, providing access to the information laid down in Part B of Annex VI;

Article 27(1a,ii)

• • a UDI production identifier (‘UDI-PI’) that identifies the unit of device production and if applicable the packaged devices, as specified in Part C of Annex VI;

Article 27(1b)

• placing of the UDI on the label of the device or on its packaging;

Article 27(1c)

• storage of the UDI by economic operators, health institutions and healthcare professionals, in accordance with the conditions laid down in paragraphs 8 and 9 of this Article respectively;

Article 10(9h)

The procedure needs to include the verification of the UDI assignments made in accordance with Article 27(3) to all relevant devices and ensuring consistency and validity of information provided in accordance with Article 29

Assignment with an issuing entity

Article 27(3)

Before placing a device, other than a custom-made device, on the market, the manufacturer shall assign to the device and, if applicable, to all higher levels of packaging, a UDI created in compliance with the rules of the issuing entity designated by the Commission in accordance with paragraph 2.

Article 29(1)

Before placing a device, other than a custom-made device, on the market, the manufacturer shall, in accordance with the rules of the issuing entity referred to in Article 27(2), assign a Basic UDI-DI as defined in Part C of Annex VI to the device

Article 29(2)

Before placing on the market a system or procedure pack pursuant to Article 22(1) and (3), that is not a custom-made device, the natural or legal person responsible shall assign to the system or procedure pack, in compliance with the rules of the issuing entity, a Basic UDI-DI

Article 29(3)

For devices that are the subject of a conformity assessment as referred to in Article 52(3) and in the second and third subparagraphs of Article 52(4), the assignment of a Basic UDI-DI referred to in paragraph 1 of this Article shall be done before the manufacturer applies to a notified body for that assessment.

Assignment of UDI to the device

Annex VI(C.3.1)

A UDI shall be assigned to the device itself or its packaging. Higher levels of packaging shall have their own UDI.

Annex VI(C.3.2)

Shipping containers shall be exempted from the requirement in Section 3.1. By way of example, a UDI shall not be required on a logistics unit; where a healthcare provider orders multiple devices using the UDI or model number of individual devices and the manufacturer places those devices in a container for shipping or to protect the individually packaged devices, the container (logistics unit) shall not be subject to UDI requirements.

Annex VI(C.3.3)

The UDI shall contain two parts: a UDI-DI and a UDI-PI.

Annex VI(C.3.4)

The UDI-DI shall be unique at each level of device packaging.

Annex VI(C.3.5)

If a lot number, serial number, software identification or expiry date appears on the label, it shall be part of the UDI-PI. If there is also a manufacturing date on the label, it does not need to be included in the UDI-PI. If there is only a manufacturing date on the label, this shall be used as the UDI-PI.

Annex VI(C.3.6)

Each component that is considered to be a device and is commercially available on its own shall be assigned a separate UDI unless the components are part of a configurable device that is marked with its own UDI

Annex VI(C.3.7)

Systems and procedure packs as referred to in Article 22 shall be assigned and bear their own UDI.

Annex VI(C.3.8)

The manufacturer shall assign the UDI to a device following the relevant coding standard.

Annex VI(C.3.9)

A new UDI-DI shall be required whenever there is a change that could lead to misidentification of the device and/or ambiguity in its traceability; in particular, any change of one of the following UDI database data elements shall require a new UDI-DI:

1. name or trade name,
2. device version or model,
3. labelled as single use,
4. packaged sterile,
5. need for sterilization before use,
6. quantity of devices provided in a package,
7. (g) critical warnings or contra-indications: e.g. containing latex or DEHP.

Annex VI(C.3.10)

Manufacturers that repackage and/or relabel devices, with their own label shall retain a record of the original device manufacturer’s UDI.

Annex VI(C.6.1.1)

Implantable device

Implantable devices shall, at their lowest level of packaging (‘unit packs’), be identified, or marked using AIDC, with a UDI (UDI-DI + UDI-PI)

Annex VI(C.6.1.2)

The UDI-PI shall have at least the following characteristics:

1. the serial number for active implantable devices,

the serial number or lot number for other implantable devices.

Annex VI(C.6.1.3)

The UDI of the implantable device shall be identifiable prior to implantation.

Annex VI(C.6.2.1)

Reusable devices requiring cleaning, disinfection, sterilisation or refurbishing between uses

The UDI of such devices shall be placed on the device and be readable after each procedure to make the device ready for the next use.

Annex VI(C.6.2.2)

The UDI-PI characteristics such as the lot or serial number shall be defined by the manufacturer.

Annex VI(C.6.3.1)

Systems and procedure packs as referred to in Article 22

The natural or legal person referred to in Article 22 shall be responsible for identifying the system or procedure pack with a UDI including both UDI-DI and UDI-PI.

Annex VI(C.6.4.1)

Configurable devices

A UDI shall be assigned to the configurable device in its entirety and shall be called the configurable device UDI.

Annex VI(C.6.4.2)

The configurable device UDI-DI shall be assigned to groups of configurations, not per configuration within the group. A group of configurations is defined as the collection of possible configurations for a given device as described in the technical documentation.

Annex VI(C.6.4.3)

A configurable device UDI-PI shall be assigned to each individual configurable device.

Annex VI(C.6.4.5)

Each component that is considered a device and is commercially available on its own shall be assigned a separate UDI.

Annex VI(C.6.5.1)

Device software

The UDI shall be assigned at the system level of the software. Only software which is commercially available on its own and software which constitutes a device in itself shall be subject to that requirement.

The software identification shall be considered to be the manufacturing control mechanism and shall be displayed in the UDI-PI.

Annex VI(C.6.5.2)

A new UDI-DI shall be required whenever there is a modification that changes:

1. the original performance;
2. the safety or the intended use of the software;
3. interpretation of data.

Such modifications include new or modified algorithms, database structures, operating platform, architecture or new user interfaces or new channels for interoperability.

Annex VI(C.6.5.3)

Minor software revisions shall require a new UDI-PI and not a new UDI-DI.

Minor software revisions are generally associated with bug fixes, usability enhancements that are not for safety purposes, security patches or operating efficiency.

Minor software revisions shall be identified by a manufacturer-specific form of identification.

UDI carrier

Article 27(4)

UDI carriers shall be placed on the label of the device and on all higher levels of packaging. Higher levels of packaging shall not be understood to include shipping containers.

Article 123(f)

Transition period

With regard to devices that bear the UDI carrier on the device labeling:

• For implantable devices and for class III devices UDI carrier requirements shall apply from 26 May 2021.
• For class IIa and class IIb devices UDI carrier requirements shall apply from 26 May 2023.
• For class I devices UDI carrier requirements shall apply from 26 May 2025;

Article 123(g)

With regard to reusable devices that are required to bear the UDI carrier on the device itself, UDI carrier requirements shall apply to:

• implantable devices and class III devices from 26 May 2023;
• class IIa and class IIb devices from 26 May 2025;
• class I devices from 26 May 2027;

Annex VI(C.4.1)

The UDI carrier (AIDC and HRI representation of the UDI) shall be placed on the label or on the device itself and on all higher levels of device packaging. Higher levels do not include shipping containers.

Annex VI(C.4.2)

In the event of there being significant space constraints on the unit of use packaging, the UDI carrier may be placed on the next higher packaging level.

Annex VI(C.4.3)

For single-use devices of classes I and IIa packaged and labelled individually, the UDI carrier shall not be required to appear on the packaging but it shall appear on a higher level of packaging, e.g. a carton containing several individually packaged devices. However, when the healthcare provider is not expected to have access, in cases such as in home healthcare settings, to the higher level of device packaging, the UDI shall be placed on the packaging of the individual device.

Annex VI(C.4.4)

For devices exclusively intended for retail point of sale the UDI-PIs in AIDC shall not be required to appear on the point of sale packaging.

Annex VI(C.4.5)

When AIDC carriers other than the UDI carrier are part of the product labelling, the UDI carrier shall be readily identifiable.

Annex VI(C.4.6)

If linear bar codes are used, the UDI-DI and UDI-PI may be concatenated or non-concatenated in two or more bar codes. All parts and elements of the linear bar code shall be distinguishable and identifiable.

Annex VI(C.4.7)

If there are significant constraints limiting the use of both AIDC and HRI on the label, only the AIDC format shall be required to appear on the label. For devices intended to be used outside healthcare facilities, such as devices for home care, the HRI shall however appear on the label even if this results in there being no space for the AIDC.

Annex VI(C.4.8)

The HRI format shall follow the rules of the UDI code-issuing entity.

Annex VI(C.4.9)

If the manufacturer is using RFID technology, a linear or 2D bar code in line with the standard provided by the issuing entities shall also be provided on the label.

Annex VI(C.4.10)

Devices that are reusable shall bear a UDI carrier on the device itself. The UDI carrier for reusable devices that require cleaning, disinfection, sterilisation or refurbishing between patient uses shall be permanent and readable after each process performed to make the device ready for the subsequent use throughout the intended lifetime of the device. The requirement of this Section shall not apply to devices in the following circumstances:

1. any type of direct marking would interfere with the safety or performance of the device;
2. the device cannot be directly marked because it is not technologically feasible.

Annex VI(C.4.11)

The UDI carrier shall be readable during normal use and throughout the intended lifetime of the device.

Annex VI(C.4.12)

If the UDI carrier is readily readable or, in the case of AIDC, scannable, through the device’s packaging, the placing of the UDI carrier on the packaging shall not be required.

Annex VI(C.4.13)

In the case of single finished devices made up of multiple parts that must be assembled before their first use, it shall be sufficient to place the UDI carrier on only one part of each device.

Annex VI(C.4.14)

The UDI carrier shall be placed in a manner such that the AIDC can be accessed during normal operation or storage.

Annex VI(C.4.15)

Bar code carriers that include both a UDI-DI and a UDI-PI may also include essential data for the device to operate or other data.

Annex VI(C.6.3.2)

Systems and procedure packs as referred to in Article 22

Device contents of system or procedure packs shall bear a UDI carrier on their packaging or on the device itself.

Exemptions:

1. individual single-use disposable devices, the uses of which are generally known to the persons by whom they are intended to be used, which are contained within a system or procedure pack, and which are not intended for individual use outside the context of the system or procedure pack, shall not be required to bear their own UDI carrier;
2. devices that are exempted from bearing a UDI carrier on the relevant level of packaging shall not be required to bear a UDI carrier when included within a system or procedure pack.

Annex VI(C.6.3.3)

Placement of the UDI carrier on systems or procedure packs

1. The system or procedure pack UDI carrier shall as a general rule be affixed to the outside of the packaging.
2. The UDI carrier shall be readable, or, in the case of AIDC, scannable, whether placed on the outside of the packaging of the system or procedure pack or inside transparent packaging.

Annex VI(C.6.4.4)

Configurable devices

The carrier of the configurable device UDI shall be placed on the assembly that is most unlikely to be exchanged during the lifetime of the system and shall be identified as the configurable device UDI.

Annex VI(C.6.4.5)

Each component that is considered a device and is commercially available on its own shall be assigned a separate UDI.

Annex VI(C.6.5.4)

Device software

UDI placement criteria for software

1. where the software is delivered on a physical medium, e.g. CD or DVD, each packaging level shall bear the human readable and AIDC representation of the complete UDI. The UDI that is applied to the physical medium containing the software and its packaging shall be identical to the UDI assigned to the system level software;
2. the UDI shall be provided on a readily accessible screen for the user in an easily-readable plain-text format, such as an ‘about’ file, or included on the start-up screen;
3. software lacking a user interface such as middleware for image conversion, shall be capable of transmitting the UDI through an application programming interface (API);
4. only the human readable portion of the UDI shall be required in electronic displays of the software. The marking of UDI using AIDC shall not be required in the electronic displays, such as ‘about’ menu, splash screen etc.;
5. the human readable format of the UDI for the software shall include the Application Identifiers (AI) for the standard used by the issuing entities, so as to assist the user in identifying the UDI and determining which standard is being used to create the UDI.

UDI device registration

Articles 10(7), 27(3)

Manufacturers shall comply with the obligations relating to the UDI system referred to in Article 27 and with the registration obligations referred to in Articles 29.

Before a device, other than a custom-made or investigational device, is placed on the market the manufacturer shall ensure that the information referred to in Part B of Annex VI of the device in question are correctly submitted and transferred to the UDI database referred to in Article 28.

Article 29(1)

Before placing a device, other than a custom-made device, on the market, the manufacturer shall provide the Basic UDI-DI to the UDI database together with the other core data elements referred to in Part B of Annex VI related to that device.

Article 29(2)

Before placing on the market a system or procedure pack pursuant to Article 22(1) and (3), that is not a custom-made device, the natural or legal person responsible shall provide a Basic UDI-DI to the UDI database together with the other core data elements referred to in Part B of Annex VI related to that system or procedure pack.

Article 29(3)

After the issuing of the relevant certificate and before placing the device on the market, the manufacturer shall provide the Basic UDI-DI to the UDI database together with the other core data elements referred to in Part B of Annex VI related to that device.

Article 29(4)

Before placing a device on the market, other than a custom-made device, the manufacturer shall enter or if, already provided, verify in Eudamed the information referred to in Section 2 of Part A of Annex VI, with the exception of Section 2.2 thereof, and shall thereafter keep the information updated.

UDI attributes – at Basic UDI-DI level

Annex VI(A.2.1)

• Basic UDI-DI

Annex VI(A.2.2)

• type, number and expiry date of the certificate issued by the notified body and the name or identification number of that notified body and the link to the information that appears on the certificate and was entered by the notified body in the electronic system on notified bodies and certificates,

Annex VI(A.2.3)

• Member State in which the device is to or has been placed on the market in the Union,

Annex VI(A.2.4)

• in the case of class IIa, class IIb or class III devices: Member States where the device is or is to be made available,

Annex VI(A.2.5)

• risk class of the device,

Annex VI(A.2.6)

• reprocessed single-use device (y/n),

Annex VI(A.2.7)

• presence of a substance which, if used separately, may be considered to be a medicinal product and name of that substance,

Annex VI(A.2.8)

• presence of a substance which, if used separately, may be considered to be a medicinal product derived from human blood or human plasma and name of this substance,

Annex VI(A.2.9)

• presence of tissues or cells of human origin, or their derivatives (y/n),

Annex VI(A.2.10)

• presence of tissues or cells of animal origin, or their derivatives, as referred to in Regulation (EU) No 722/2012 (y/n),

Annex VI(A.2.11)

• where applicable, the single identification number of the clinical investigation or investigations conducted in relation to the device or a link to the clinical investigation registration in the electronic system on clinical investigations,

Annex VI(A.2.12)

• in the case of devices listed in Annex XVI, specification as to whether the intended purpose of the device is other than a medical purpose,

Annex VI(A.2.13)

• in the case of devices designed and manufactured by another legal or natural person as referred in Article 10(15), the name, address and contact details of that legal or natural person,

Annex VI(A.2.14)

• in the case of class III or implantable devices, the summary of safety and clinical performance,

Annex VI(A.2.15)

• status of the device (on the market, no longer placed on the market, recalled, field safety corrective action initiated).

UDI attributes – at UDI-DI level

Annex VI (B.1)

• quantity per package configuration,

Annex VI (B.2)

• the Basic UDI-DI as referred to in Article 29 and any additional UDI-DIs,

Annex VI (B.3)

• the manner in which production of the device is controlled (expiry date or manufacturing date, lot number, serial number),

Annex VI (B.4)

• if applicable, the unit of use UDI-DI (where a UDI is not labelled on the device at the level of its unit of use, a ‘unit of use’ DI shall be assigned so as to associate the use of a device with a patient),

Annex VI (B.5)

• name and address of the manufacturer (as indicated on the label),

Annex VI (B.6)

• the SRN issued in accordance with Article 31(2),

Annex VI (B.7)

• if applicable, name and address of the authorised representative (as indicated on the label),

Annex VI (B.8)

• the medical device nomenclature code as provided for in Article 26,

Annex VI (B.9)

• risk class of the device,

Annex VI (B.10)

• if applicable, name or trade name,

Annex VI (B.11)

• if applicable, device model, reference, or catalogue number,

Annex VI (B.12)

• if applicable, clinical size (including volume, length, gauge, diameter),

Annex VI (B.13)

• additional product description (optional),

Annex VI (B.14)

• if applicable, storage and/or handling conditions (as indicated on the label or in the instructions for use),

Annex VI (B.15)

• if applicable, additional trade names of the device,

Annex VI (B.16)

• labelled as a single-use device (y/n),

Annex VI (B.17)

• if applicable, the maximum number of reuses,

Annex VI (B.18)

• device labelled sterile (y/n),

Annex VI (B.19)

• need for sterilisation before use (y/n),

Annex VI (B.20)

• containing latex (y/n),

Annex VI (B.21)

• where applicable, information labelled in accordance with Section 10.4.5 of Annex I,

Annex VI (B.22)

• URL for additional information, such as electronic instructions for use (optional),

Annex VI (B.23)

• if applicable, critical warnings or contra-indications,

Annex VI (B.24)

• status of the device (on the market, no longer placed on the market, recalled, field safety corrective action initiated).

Description:

Article 10(8)

Manufacturers shall keep the technical documentation, the EU declaration of conformity and, if applicable, a copy of any relevant certificate, including any amendments and supplements, issued in accordance with Article 56, available for the competent authorities for a period of at least 10 years after the last device covered by the EU declaration of conformity has been placed on the market. In the case of implantable devices, the period shall be at least 15 years after the last device has been placed on the market.

Upon request by a competent authority, the manufacturer shall, as indicated therein, provide that technical documentation in its entirety or a summary thereof.

Description:

UDI

Article 27(5)

The UDI shall be used for reporting serious incidents and field safety corrective actions in accordance with Article 87.

Vigilance procedure

Articles 10(9k), 10(13)

The QMS needs to include processes for reporting of serious incidents and field safety corrective actions in the context of vigilance;

Manufacturers shall have a system for recording and reporting of incidents and field safety corrective actions as described in Articles 87 and 88.

Definitions

Article 87(1)

Manufacturers of devices made available on the Union market, other than investigational devices, shall report, to the relevant competent authorities, in accordance with Articles 92(5) and (7), the following:

1. any serious incident involving devices made available on the Union market, except expected side-effects which are clearly documented in the product information and quantified in the technical documentation and are subject to trend reporting pursuant to Article 88;

EUDAMED

Article 87(1)

The reports referred to in the first subparagraph shall be submitted through the electronic system referred to in Article 92

Reporting criteria

Article 87(2)

As a general rule, the period for the reporting referred to in paragraph 1 shall take account of the severity of the serious incident.

Article 87(3)

Manufacturers shall report any serious incident as referred to in point (a) of paragraph 1 immediately after they have established the causal relationship between that incident and their device or that such causal relationship is reasonably possible and not later than 15 days after they become aware of the incident.

Article 87(4)

Notwithstanding paragraph 3, in the event of a serious public health threat the report referred to in paragraph 1 shall be provided immediately, and not later than 2 days after the manufacturer becomes aware of that threat.

Article 87(5)

Notwithstanding paragraph 3, in the event of death or an unanticipated serious deterioration in a person’s state of health the report shall be provided immediately after the manufacturer has established or as soon as it suspects a causal relationship between the device and the serious incident but not later than 10 days after the date on which the manufacturer becomes aware of the serious incident.

Type of reports

Article 87(6)

Where necessary to ensure timely reporting, the manufacturer may submit an initial report that is incomplete followed up by a complete report.

Article 87(7)

If, after becoming aware of a potentially reportable incident, the manufacturer is uncertain about whether the incident is reportable, it shall nevertheless submit a report within the timeframe required in accordance with paragraphs 2 to 5.

Article 87(9)

For similar serious incidents that occur with the same device or device type and for which the root cause has been identified or a field safety corrective action implemented or where the incidents are common and well documented, the manufacturer may provide periodic summary reports instead of individual serious incident reports, on condition that the coordinating competent authority referred to in Article 89(9), in consultation with the competent authorities referred to in point (a) of Article 92(8), has agreed with the manufacturer on the format, content and frequency of the periodic summary reporting. Where a single competent authority is referred to in points (a) and (b) of Article 92(8), the manufacturer may provide periodic summary reports following agreement with that competent authority.

Healthcare institutions

Article 87(10)

Where a competent authority of a Member State obtains such reports on suspected serious incidents referred to in point (a) of paragraph 1 from healthcare professionals, users or patients, it shall take the necessary steps to ensure that the manufacturer of the device concerned is informed of the suspected serious incident without delay.

• Where the manufacturer of the device concerned considers that the incident is a serious incident, it shall provide a report in accordance with paragraphs 1 to 5 of this Article on that serious incident to the competent authority of the Member State in which that serious incident occurred and shall take the appropriate follow-up action in accordance with Article 89.
• Where the manufacturer of the device concerned considers that the incident is not a serious incident or is an expected undesirable side-effect, which will be covered by trend reporting in accordance with Article 88, it shall provide an explanatory statement. If the competent authority does not agree with the conclusion of the explanatory statement, it may require the manufacturer to provide a report in accordance with paragraphs 1 to 5 of this Article and require it to ensure that appropriate follow-up action is taken in accordance with Article 89.

Description:

UDI

Article 27(5)

The UDI shall be used for reporting serious incidents and field safety corrective actions in accordance with Article 87.

FSCA procedure

Articles 10(9k), 10(13)

The QMS needs to include processes for reporting of serious incidents and field safety corrective actions in the context of vigilance;

Manufacturers shall have a system for recording and reporting of incidents and field safety corrective actions as described in Articles 87 and 88.

Definitions

Article 87(1)

Manufacturers of devices made available on the Union market, other than investigational devices, shall report, to the relevant competent authorities, in accordance with Articles 92(5) and (7), the following:

1. any field safety corrective action in respect of devices made available on the Union market, including any field safety corrective action undertaken in a third country in relation to a device which is also legally made available on the Union market, if the reason for the field safety corrective action is not limited to the device made available in the third country.

Reporting criteria

Article 89(1)

Following the reporting of a serious incident pursuant to Article 87(1), the manufacturer shall, without delay, perform the necessary investigations in relation to the serious incident and the devices concerned. This shall include a risk assessment of the incident and field safety corrective action taking into account criteria as referred to in paragraph 3 of this Article as appropriate.

Note: The manufacturer shall co-operate with the competent authorities and where relevant with the notified body concerned during the investigations referred to in the first subparagraph and shall not perform any investigation which involves altering the device or a sample of the batch concerned in a way which may affect any subsequent evaluation of the causes of the incident, prior to informing the competent authorities of such action.

Communication with CA

Article 89(3)

Upon request by the national competent authority, manufacturers shall provide all documents necessary for the risk assessment.

Article 89(5)

The manufacturer shall provide a final report to the competent authority setting out its findings from the investigation by means of the electronic system referred to in Article 92. The report shall set out conclusions and where relevant indicate corrective actions to be taken.

FSCA

Article 87(8)

Except in cases of urgency in which the manufacturer needs to undertake field safety corrective action immediately, the manufacturer shall, without undue delay, report the field safety corrective action referred to in point (b) of paragraph 1 in advance of the field safety corrective action being undertaken.

FSN

Article 89(9)

The manufacturer shall ensure that information about the field safety corrective action taken is brought without delay to the attention of users of the device in question by means of a field safety notice.

Article 89(9)

The field safety notice shall be edited in an official Union language or languages determined by the Member State in which the field safety corrective action is taken.

Article 89(9)

Except in cases of urgency, the content of the draft field safety notice shall be submitted to the evaluating competent authority or, in the cases referred to in paragraph 9, to the coordinating competent authority to allow it to make comments. Unless duly justified by the situation of the individual Member State, the content of the field safety notice shall be consistent in all Member States.

Article 89(9)

The field safety notice shall allow the correct identification of the device or devices involved, in particular by including the relevant UDIs, and the correct identification, in particular, by including the SRN, if already issued, of the manufacturer that has undertaken the field safety corrective action. The field safety notice shall explain, in a clear manner, without understating the level of risk, the reasons for the field safety corrective action with reference to the device malfunction and associated risks for patients, users or other persons, and shall clearly indicate all the actions to be taken by users.

Article 89(9)

The manufacturer shall enter the field safety notice in the electronic system referred to in Article 92 through which that notice shall be accessible to the public.

Description:

Qualifications

Article 15(1)

Manufacturers shall have available within their organisation at least one person responsible for regulatory compliance who possesses the requisite expertise in the field of medical devices. The requisite expertise shall be demonstrated by either of the following qualifications:

Article 15(1a,b)

• a diploma, certificate or other evidence of formal qualification, awarded on completion of a university degree or of a course of study recognised as equivalent by the Member State concerned, in law, medicine, pharmacy, engineering or another relevant scientific discipline, and at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices;
• four years of professional experience in regulatory affairs or in quality management systems relating to medical devices.

Qualifications for Custom made device

Article 15(1)

Without prejudice to national provisions regarding professional qualifications, manufacturers of custom-made devices may demonstrate the requisite expertise referred to in the first subparagraph by having at least two years of professional experience within a relevant field of manufacturing.

Small organizations

Article 15(2)

Micro and small enterprises within the meaning of Commission Recommendation 2003/361/EC ( 3 ) shall not be required to have the person responsible for regulatory compliance within their organisation but shall have such person permanently and continuously at their disposal.

PRRC responsibilities

Article 15(3)

The person responsible for regulatory compliance shall at least be responsible for ensuring that:

Article 15(3a)

• the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released;

Article 15(3b)

• the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date;

Article 15(3c)

• the post-market surveillance obligations are complied with in accordance with Article 10(10);

Article 15(3d)

• the reporting obligations referred to in Articles 87 to 91 are fulfilled;

Article 15(3e)

• in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued.

Multiple PRRCs

Article 15(4)

If a number of persons are jointly responsible for regulatory compliance in accordance with paragraphs 1, 2 and 3, their respective areas of responsibility shall be stipulated in writing.

Article 15(5)

The person responsible for regulatory compliance shall suffer no disadvantage within the manufacturer’s organisation in relation to the proper fulfilment of his or her duties, regardless of whether or not they are employees of the organisation.

Description:

Manufacturer registration

Article 10(7)

Manufacturers shall comply with the with the registration obligations referred to in Article 31.

Article 31(3)

The manufacturer shall use the SRN when applying to a notified body for conformity assessment and for accessing Eudamed in order to fulfil its obligations under Article 29.

Articles 31(1), (2)

SRN

Before placing a device, other than a custom-made device, on the market, manufacturers, authorised representatives and importers shall, in order to register, submit to the electronic system referred to in Article 30 the information referred to in Section 1 of Part A of Annex VI, provided that they have not already registered in accordance with this Article.

Note: In cases where the conformity assessment procedure requires the involvement of a notified body pursuant to Article 52, the information referred to in Section 1 of Part A of Annex VI shall be provided to that electronic system before applying to the notified body.

Note: After having verified the data entered pursuant to paragraph 1, the competent authority shall obtain a single registration number (‘SRN’) from the electronic system referred to in Article 30 and issue it to the manufacturer, the authorised representative or the importer.

SRN number:

Article 31(4)

Change to the EO registration information

Within one week of any change occurring in relation to the information referred to in paragraph 1 of this Article, the economic operator shall update the data in the electronic system referred to in Article 30.

Article 31(5), (6)

Confirmation of accuracy of information

Not later than one year after submission of the information in accordance with paragraph 1, and every second year thereafter, the economic operator shall confirm the accuracy of the data. In the event of a failure to do so within six months of those deadlines, any Member State may take appropriate corrective measures within its territory until that economic operator complies with that obligation.

Note: Without prejudice to the economic operator’s responsibility for the data, the competent authority shall verify the confirmed data referred to in Section 1 of Part A of Annex VI.

Economic operator attributes

Annex VI(A.1.1)

• type of economic operator(manufacturer, authorised representative, or importer),

Annex VI(A.1.2)

• name, address and contact details of the economic operator,

Annex VI(A.1.3)

• where submission of information is carried out by another person on behalf of any of the economic operators mentioned under Section 1.1, the name, address and contact details of that person,

Annex VI(A.1.4)

• name address and contact details of the person or persons responsible for regulatory compliance

Specific manufacturer obligations

Article 10(12)

FSCA

Manufacturers who consider or have reason to believe that a device which they have placed on the market or put into service is not in conformity with this Regulation shall immediately take the necessary corrective action to bring that device into conformity, to withdraw it or to recall it, as appropriate. They shall inform the distributors of the device in question and, where applicable, the authorised representative and importers accordingly.

Where the device presents a serious risk, manufacturers shall immediately inform the competent authorities of the Member States in which they made the device available and, where applicable, the notified body that issued a certificate for the device in accordance with Article 56, in particular, of the non-compliance and of any corrective action taken.

Article 10(14)

CA request

Manufacturers shall, upon request by a competent authority, provide it with all the information and documentation necessary to demonstrate the conformity of the device, in an official Union language determined by the Member State concerned. The competent authority of the Member State in which the manufacturer has its registered place of business may require that the manufacturer provide samples of the device free of charge or, where that is impracticable, grant access to the device. Manufacturers shall cooperate with a competent authority, at its request, on any corrective action taken to eliminate or, if that is not possible, mitigate the risks posed by devices which they have placed on the market or put into service.

Article 10(14)

If the manufacturer fails to cooperate or the information and documentation provided is incomplete or incorrect, the competent authority may, in order to ensure the protection of public health and patient safety, take all appropriate measures to prohibit or restrict the device’s being made available on its national market, to withdraw the device from that market or to recall it until the manufacturer cooperates or provides complete and correct information.

Article 10(14)

If a competent authority considers or has reason to believe that a device has caused damage, it shall, upon request, facilitate the provision of the information and documentation referred to in the first subparagraph to the potentially injured patient or user and, as appropriate, the patient’s or user’s successor in title, the patient’s or user’s health insurance company or other third parties affected by the damage caused to the patient or user, without prejudice to data protection rules and, unless there is an overriding public interest in disclosure, without prejudice to the protection of intellectual property rights.

Design/Manufacturing owner

Article 10(15)

Where manufacturers have their devices designed or manufactured by another legal or natural person the information on the identity of that person shall be part of the information to be submitted in accordance with Article 29(4).

Liability

Article 10(16)

Natural or legal persons may claim compensation for damage caused by a defective device in accordance with applicable Union and national law.

Manufacturers shall, in a manner that is proportionate to the risk class, type of device and the size of the enterprise, have measures in place to provide sufficient financial coverage in respect of their potential liability under Directive 85/374/EEC, without prejudice to more protective measures under national law.

Confidentiality of information and data protection

Article 109(1)

Unless otherwise provided for in this Regulation and without prejudice to existing national provisions and practices in the Member States on confidentiality, all parties involved in the application of this Regulation shall respect the confidentiality of information and data obtained in carrying out their tasks in order to protect the following:

1. personal data, in accordance with Article 110;
2. commercially confidential information and trade secrets of a natural or legal person, including intellectual property rights; unless disclosure is in the public interest;
3. the effective implementation of this Regulation, in particular for the purpose of inspections, investigations or audits.

Obligations in case of interruption or discontinuation of supply of certain devices

Article 10a(1)

Where a manufacturer anticipates an interruption or a discontinuation of the supply of a device, other than a custom-made device, and where it is reasonably foreseeable that such interruption or discontinuation could result in serious harm or a risk of serious harm to patients or public health in one or more Member States, the manufacturer shall inform the competent authority of the Member State where it or its authorised representative is established, as well as the economic operators, health institutions and healthcare professionals to whom it directly supplies the device, of the anticipated interruption or discontinuation.

Article 10a(1)

The information referred to in the first subparagraph shall, other than in exceptional circumstances, be provided at least 6 months before the anticipated interruption or discontinuation. The manufacturer shall specify the reasons for the interruption or discontinuation in the information provided to the competent authority.

Article 10a(3)

The economic operators who have received the information from the manufacturer in accordance with paragraph 1 or from another economic operator in the supply chain shall, without undue delay, inform any other economic operators, health institutions and healthcare professionals to whom they directly supply the device, of the anticipated interruption or discontinuation.’;

Article 120(13)

Article 10a shall also apply to legacy devices

Description:

Definition

Article 10(8)

A manufacturer with a registered place of business outside the Union shall, in order to allow its authorised representative to fulfil the tasks mentioned in Article 11(3), ensure that the authorised representative has the necessary documentation permanently available.

Article 11(1)

Where the manufacturer of a device is not established in a Member State, the device may only be placed on the Union market if the manufacturer designates a sole authorised representative.

Mandate

Article 11(2)

The designation shall constitute the authorised representative’s mandate, it shall be valid only when accepted in writing by the authorised representative and shall be effective at least for all devices of the same generic device group.

Article 11(3)

The authorised representative shall perform the tasks specified in the mandate agreed between it and the manufacturer. The authorised representative shall provide a copy of the mandate to the competent authority, upon request.

Article 11(4)

The mandate referred to in paragraph 3 of this Article shall not delegate the manufacturer’s obligations laid down in:

• Article 10(1) Compliance to MDR
• Article 10 (2) Risk Management System
• Article 10 (3) Clinical evaluation
• Article 10 (4) Technical documentation
• Article 10 (6) DoC and CE marking
• Article 10 (7) UDI system and registration obligations
• Article 10 (9) QMS
• Article 10 (10) PMS
• Article 10 (11) Labeling and translation
• Article 10 (12) FSCA

PRRC

Article 15(6)

Authorised representatives shall have permanently and continuously at their disposal at least one person responsible for regulatory compliance who possesses the requisite expertise regarding the regulatory requirements for medical devices in the Union. The requisite expertise shall be demonstrated by either of the following qualifications:

Article 15(6a)

• a diploma, certificate or other evidence of formal qualification, awarded on completion of a university degree or of a course of study recognised as equivalent by the Member State concerned, in law, medicine, pharmacy, engineering or another relevant scientific discipline, and at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices;

Article 15(6b)

• four years of professional experience in regulatory affairs or in quality management systems relating to medical devices.

EUAR registration

Articles 31(1), (2)

SRN

Before placing a device, other than a custom-made device, on the market, manufacturers, authorised representatives and importers shall, in order to register, submit to the electronic system referred to in Article 30 the information referred to in Section 1 of Part A of Annex VI, provided that they have not already registered in accordance with this Article.

Note: In cases where the conformity assessment procedure requires the involvement of a notified body pursuant to Article 52, the information referred to in Section 1 of Part A of Annex VI shall be provided to that electronic system before applying to the notified body.

Note: After having verified the data entered pursuant to paragraph 1, the competent authority shall obtain a single registration number (‘SRN’) from the electronic system referred to in Article 30 and issue it to the manufacturer, the authorised representative or the importer.

SRN number:

Article 31(4)

Change to the EO registration information

Within one week of any change occurring in relation to the information referred to in paragraph 1 of this Article, the economic operator shall update the data in the electronic system referred to in Article 30.

Article 31(5), (6)

Confirmation of accuracy of information

Not later than one year after submission of the information in accordance with paragraph 1, and every second year thereafter, the economic operator shall confirm the accuracy of the data. In the event of a failure to do so within six months of those deadlines, any Member State may take appropriate corrective measures within its territory until that economic operator complies with that obligation.

Note: Without prejudice to the economic operator’s responsibility for the data, the competent authority shall verify the confirmed data referred to in Section 1 of Part A of Annex VI.

Economic operator attributes

Annex VI(A.1.1)

• type of economic operator(manufacturer, authorised representative, or importer),

Annex VI(A.1.2)

• name, address and contact details of the economic operator,

Annex VI(A.1.3)

• where submission of information is carried out by another person on behalf of any of the economic operators mentioned under Section 1.1, the name, address and contact details of that person,

Annex VI(A.1.4)

• name address and contact details of the person or persons responsible for regulatory compliance

Mandates and obligations

Article 11(3)

The mandate shall require, and the manufacturer shall enable, the authorised representative to perform at least the following tasks in relation to the devices that it covers:

–

Verification activities

Article 11(3a)

• verify that the EU declaration of conformity and technical documentation have been drawn up and, where applicable, that an appropriate conformity assessment procedure has been carried out by the manufacturer;

Article 11(3b)

• keep available a copy of the technical documentation, the EU declaration of conformity and, if applicable, a copy of the relevant certificate, including any amendments and supplements, issued in accordance with Article 56, at the disposal of competent authorities for the period referred to in Article 10(8);

Article 11(3c)

• comply with the registration obligations laid down in Article 31 and verify that the manufacturer has complied with the registration obligations laid down in Articles 27 and 29;

–

CA request

Article 11(3d)

• in response to a request from a competent authority, provide that competent authority with all the information and documentation necessary to demonstrate the conformity of a device, in an official Union language determined by the Member State concerned;

Article 11(3e)

• forward to the manufacturer any request by a competent authority of the Member State in which the authorised representative has its registered place of business for samples, or access to a device and verify that the competent authority receives the samples or is given access to the device;

–

FSCA

Article 11(3f)

• cooperate with the competent authorities on any preventive or corrective action taken to eliminate or, if that is not possible, mitigate the risks posed by devices;

–

Complaints

Article 11(3g)

• immediately inform the manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents related to a device for which they have been designated;

–

Contract termination

Article 11(3h)

• terminate the mandate if the manufacturer acts contrary to its obligations under this Regulation.

Responsibilities

Article 11(5)

Without prejudice to paragraph 4 of this Article, where the manufacturer is not established in a Member State and has not complied with the obligations laid down in Article 10, the authorised representative shall be legally liable for defective devices on the same basis as, and jointly and severally with, the manufacturer.

Termination of mandate

Article 11(6)

An authorised representative who terminates its mandate on the ground referred to in point (h) of paragraph 3 shall immediately inform the competent authority of the Member State in which it is established and, where applicable, the notified body that was involved in the conformity assessment for the device of the termination of the mandate and the reasons therefor.

Article 11(7)

Any reference in this Regulation to the competent authority of the Member State in which the manufacturer has its registered place of business shall be understood as a reference to the competent authority of the Member State in which the authorised representative, designated by a manufacturer referred to in paragraph 1, has its registered place of business.

Change to NB

Article 12

The detailed arrangements for a change of authorised representative shall be clearly defined in an agreement between the manufacturer, where practicable the outgoing authorised representative, and the incoming authorised representative. That agreement shall address at least the following aspects:

Article 12(a)

• the date of termination of the mandate of the outgoing authorised representative and date of beginning of the mandate of the incoming authorised representative

Article 12(b)

• the date until which the outgoing authorised representative may be indicated in the information supplied by the manufacturer, including any promotional material;

Article 12(c)

• the transfer of documents, including confidentiality aspects and property rights;

Article 12(d)

• the obligation of the outgoing authorised representative after the end of the mandate to forward to the manufacturer or incoming authorised representative any complaints or reports from healthcare professionals, patients or users about suspected incidents related to a device for which it had been designated as authorised representative.

Description:

Definition

Article 13(1)

Importers shall place on the Union market only devices that are in conformity with this Regulation.

Verification activities

Article 13(2)

In order to place a device on the market, importers shall verify that:

Article 13(2a)

• the device has been CE marked and that the EU declaration of conformity of the device has been drawn up;

Article 13(2b)

• a manufacturer is identified and that an authorised representative in accordance with Article 11 has been designated by the manufacturer;

Article 13(2c)

• the device is labelled in accordance with this Regulation and accompanied by the required instructions for use;

Article 13(2d)

• where applicable, a UDI has been assigned by the manufacturer in accordance with Article 27.

Articles 13(4), 30(3)

Within two weeks of placing a device, other than a custom-made device, on the market, importers shall verify that the manufacturer or authorised representative has provided to the electronic system the information referred to in paragraph 1.

• Where applicable, importers shall inform the relevant authorised representative or manufacturer if the information referred to in paragraph 1 is not included or is incorrect.
• Importers shall add their details to the relevant entry/entries.

Importer registration

Articles 31(1), (2)

SRN

Before placing a device, other than a custom-made device, on the market, manufacturers, authorised representatives and importers shall, in order to register, submit to the electronic system referred to in Article 30 the information referred to in Section 1 of Part A of Annex VI, provided that they have not already registered in accordance with this Article.

Note: In cases where the conformity assessment procedure requires the involvement of a notified body pursuant to Article 52, the information referred to in Section 1 of Part A of Annex VI shall be provided to that electronic system before applying to the notified body.

Note: After having verified the data entered pursuant to paragraph 1, the competent authority shall obtain a single registration number (‘SRN’) from the electronic system referred to in Article 30 and issue it to the manufacturer, the authorised representative or the importer.

SRN number:

Article 31(4)

Change to the EO registration information

Within one week of any change occurring in relation to the information referred to in paragraph 1 of this Article, the economic operator shall update the data in the electronic system referred to in Article 30.

Article 31(5), (6)

Confirmation of accuracy of information

Not later than one year after submission of the information in accordance with paragraph 1, and every second year thereafter, the economic operator shall confirm the accuracy of the data. In the event of a failure to do so within six months of those deadlines, any Member State may take appropriate corrective measures within its territory until that economic operator complies with that obligation.

Note: Without prejudice to the economic operator’s responsibility for the data, the competent authority shall verify the confirmed data referred to in Section 1 of Part A of Annex VI.

Economic operator attributes

Annex VI(A.1.1)

• type of economic operator(manufacturer, authorised representative, or importer),

Annex VI(A.1.2)

• name, address and contact details of the economic operator,

Annex VI(A.1.3)

• where submission of information is carried out by another person on behalf of any of the economic operators mentioned under Section 1.1, the name, address and contact details of that person,

Annex VI(A.1.4)

• name address and contact details of the person or persons responsible for regulatory compliance

Non-conforming products/FSCA

Article 13(2)

NC products not released on the market

Where an importer considers or has reason to believe that a device is not in conformity with the requirements of this Regulation, it shall not place the device on the market until it has been brought into conformity and shall inform the manufacturer and the manufacturer’s authorised representative. Where the importer considers or has reason to believe that the device presents a serious risk or is a falsified device, it shall also inform the competent authority of the Member State in which the importer is established.

Article 13(7)

FSCA

Importers who consider or have reason to believe that a device which they have placed on the market is not in conformity with this Regulation shall immediately inform the manufacturer and its authorised representative. Importers shall co-operate with the manufacturer, the manufacturer’s authorised representative and the competent authorities to ensure that the necessary corrective action to bring that device into conformity, to withdraw or recall it is taken. Where the device presents a serious risk, they shall also immediately inform the competent authorities of the Member States in which they made the device available and, if applicable, the notified body that issued a certificate in accordance with Article 56 for the device in question, giving details, in particular, of the non-compliance and of any corrective action taken.

Article 13(10)

CA request

Importers shall cooperate with competent authorities, at the latters’ request, on any action taken to eliminate or, if that is not possible, mitigate the risks posed by devices which they have placed on the market. Importers, upon request by a competent authority of the Member State in which the importer has its registered place of business, shall provide samples of the device free of charge or, where that is impracticable, grant access to the device.

Importer obligations

Article 13(3)

Importers shall indicate on the device or on its packaging or in a document accompanying the device their name, registered trade name or registered trade mark, their registered place of business and the address at which they can be contacted, so that their location can be established. They shall ensure that any additional label does not obscure any information on the label provided by the manufacturer.

Article 13(5)

Importers shall ensure that, while a device is under their responsibility, storage or transport conditions do not jeopardise its compliance with the general safety and performance requirements set out in Annex I and shall comply with the conditions set by the manufacturer, where available.

Article 13(6)

Importers shall keep a register of complaints, of non-conforming devices and of recalls and withdrawals, and provide the manufacturer, authorised representative and distributors with any information requested by them, in order to allow them to investigate complaints.

Complaints

Article 13(8)

Importers who have received complaints or reports from healthcare professionals, patients or users about suspected incidents related to a device which they have placed on the market shall immediately forward this information to the manufacturer and its authorised representative.

Retention policy

Article 13(9)

Importers shall, for the period referred to in Article 10(8), keep a copy of the EU declaration of conformity and, if applicable, a copy of any relevant certificate, including any amendments and supplements, issued in accordance with Article 56.

Description:

Definition

Article 14(1)

When making a device available on the market, distributors shall, in the context of their activities, act with due care in relation to the requirements applicable.

Verification activities

Article 14(2)

Before making a device available on the market, distributors shall verify that all of the following requirements are met:

Article 14(2a)

• the device has been CE marked and that the EU declaration of conformity of the device has been drawn up;

Article 14(2b)

• the device is accompanied by the information to be supplied by the manufacturer in accordance with Article 10(11);

Article 14(2c)

• for imported devices, the importer has complied with the requirements set out in Article 13(3);

Article 14(2d)

• that, where applicable, a UDI has been assigned by the manufacturer.

Article 14(2)

In order to meet the requirements referred to in points (a), (b) and (d) of the first subparagraph the distributor may apply a sampling method that is representative of the devices supplied by that distributor.

Distributor obligations

Article 14(3)

Distributors shall ensure that, while the device is under their responsibility, storage or transport conditions comply with the conditions set by the manufacturer.

Distributor registrations

Article 30(2)

Member States may maintain or introduce national provisions on registration of distributors of devices which have been made available on their territory.

Non-conforming product/FSCA

Article 14(2)

Where a distributor considers or has reason to believe that a device is not in conformity with the requirements of this Regulation, it shall not make the device available on the market until it has been brought into conformity, and shall inform the manufacturer and, where applicable, the manufacturer’s authorised representative, and the importer. Where the distributor considers or has reason to believe that the device presents a serious risk or is a falsified device, it shall also inform the competent authority of the Member State in which it is established.

Article 14(4)

Distributors that consider or have reason to believe that a device which they have made available on the market is not in conformity with this Regulation shall immediately inform the manufacturer and, where applicable, the manufacturer’s authorised representative and the importer. Distributors shall co-operate with the manufacturer and, where applicable, the manufacturer’s authorised representative, and the importer, and with competent authorities to ensure that the necessary corrective action to bring that device into conformity, to withdraw or to recall it, as appropriate, is taken. Where the distributor considers or has reason to believe that the device presents a serious risk, it shall also immediately inform the competent authorities of the Member States in which it made the device available, giving details, in particular, of the non-compliance and of any corrective action taken.

Complaints

Article 14(5)

Distributors that have received complaints or reports from healthcare professionals, patients or users about suspected incidents related to a device they have made available, shall immediately forward this information to the manufacturer and, where applicable, the manufacturer’s authorised representative, and the importer. They shall keep a register of complaints, of non-conforming devices and of recalls and withdrawals, and keep the manufacturer and, where available, the authorised representative and the importer informed of such monitoring and provide them with any information upon their request.

CA cooperation

Article 14(6)

Distributors shall, upon request by a competent authority, provide it with all the information and documentation that is at their disposal and is necessary to demonstrate the conformity of a device.

Article 14(6)

Distributors shall be considered to have fulfilled the obligation referred to in the first subparagraph when the manufacturer or, where applicable, the authorised representative for the device in question provides the required information. Distributors shall cooperate with competent authorities, at their request, on any action taken to eliminate the risks posed by devices which they have made available on the market. Distributors, upon request by a competent authority, shall provide free samples of the device or, where that is impracticable, grant access to the device.

Description:

Distributor becomes manufacturer

Article 16(1)

A distributor, importer or other natural or legal person shall assume the obligations incumbent on manufacturers if it does any of the following:

Article 16(1a)

• makes available on the market a device under its name, registered trade name or registered trade mark, except in cases where a distributor or importer enters into an agreement with a manufacturer whereby the manufacturer is identified as such on the label and is responsible for meeting the requirements placed on manufacturers in this Regulation;

Article 16(1b)

• changes the intended purpose of a device already placed on the market or put into service;

Article 16(1c)

• modifies a device already placed on the market or put into service in such a way that compliance with the applicable requirements may be affected.

Restrictions

Article 16(1)

N/A for manufacturers

The first subparagraph shall not apply to any person who, while not considered a manufacturer as defined in point (30) of Article 2, assembles or adapts for an individual patient a device already on the market without changing its intended purpose.

Article 16(2)

Exemption: repackager/relabeller

For the purposes of point (c) of paragraph 1, the following shall not be considered to be a modification of a device that could affect its compliance with the applicable requirements:

Article 16(2a)

• provision, including translation, of the information supplied by the manufacturer, in accordance with Section 23 of Annex I, relating to a device already placed on the market and of further information which is necessary in order to market the device in the relevant Member State;

Article 16(2b)

• changes to the outer packaging of a device already placed on the market, including a change of pack size, if the repackaging is necessary in order to market the device in the relevant Member State and if it is carried out in such conditions that the original condition of the device cannot be affected by it. In the case of devices placed on the market in sterile condition, it shall be presumed that the original condition of the device is adversely affected if the packaging that is necessary for maintaining the sterile condition is opened, damaged or otherwise negatively affected by the repackaging.

Article 16(3)

Specific labelling

A distributor or importer that carries out any of the activities mentioned in points (a) and (b) of paragraph 2 shall indicate on the device or, where that is impracticable, on its packaging or in a document accompanying the device, the activity carried out together with its name, registered trade name or registered trade mark, registered place of business and the address at which it can be contacted, so that its location can be established.

Article 16(3)

QMS

Distributors and importers shall ensure that they have in place a quality management system that includes procedures which ensure that the translation of information is accurate and up-to-date, and that the activities mentioned in points (a) and (b) of paragraph 2 are performed by a means and under conditions that preserve the original condition of the device and that the packaging of the repackaged device is not defective, of poor quality or untidy. The quality management system shall cover, inter alia, procedures ensuring that the distributor or importer is informed of any corrective action taken by the manufacturer in relation to the device in question in order to respond to safety issues or to bring it into conformity with this Regulation.

Article 16(4)

Communication to CA

At least 28 days prior to making the relabelled or repackaged device available on the market, distributors or importers carrying out any of the activities mentioned in points (a) and (b) of paragraph 2 shall inform the manufacturer and the competent authority of the Member State in which they plan to make the device available of the intention to make the relabelled or repackaged device available and, upon request, shall provide the manufacturer and the competent authority with a sample or mock-up of the relabelled or repackaged device, including any translated label and instructions for use.

Article 16(4)

NB certificate

Within the same period of 28 days, the distributor or importer shall submit to the competent authority a certificate, issued by a notified body designated for the type of devices that are subject to activities mentioned in points (a) and (b) of paragraph 2, attesting that the quality management system of the distributer or importer complies with the requirements laid down in paragraph 3.