EU Regulatory Strategy Report

Revision

Date

Change History

CA

Competent authority

EMA

European medicines agency

EU

European union

GSPR

General safety and performance requirements

IVDR

In vitro diagnostic medical devices regulation

MDR

Medical devices regulation

MDCG

Medical device coordinating group

N/A

Not applicable

NBOp

Notified body opinion

PMCF

Post-market clinical follow-up

PMS

Post-market surveillance

PSUR

Periodic safety update report

UDI

Unique device identification

UDI-DI

UDI- Device identifier

UDI-PI

UDI-Production identifier

WET

Well-established technology

Duration of use

Tick the box via “◼”

◻ Transient

◻ Short term

◻ Long term

◻ Implantable

Invasive device

◻ Non-invasive device

◻ Surgically invasive device

◻ Invasive device via body orifice

◻ Reusable surgical instrument

Active device

◻ Non-active device

◻ Active device

◻ Active therapeutic device

◻ Active device intended for diagnosis and monitoring

◻ Software

WET

◻ Yes, the device is part of the list in Article 52.4 and the WET is confirmed by the state of the art of similar devices.

◻ No

Devices covered by Article 52.4: sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors.

A comparison with similar devices is required with consideration of criteria (1 to 3) from MDCG 2020-6.

Non-invasive devices

Rule 1

All non-invasive devices are classified as class I, unless one of the rules set out hereinafter applies.

Rule 2

All non-invasive devices intended for channelling or storing blood, body liquids, cells or tissues, liquids or gases for the purpose of eventual infusion, administration or introduction into the body are classified as class IIa:

— if they may be connected to a class IIa, class IIb or class III active device; or

— if they are intended for use for channelling or storing blood or other body liquids or for storing organs, parts of organs or body cells and tissues, except for blood bags; blood bags are classified as class IIb.

In all other cases, such devices are classified as class I.

Rule 3

All non-invasive devices intended for modifying the biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body are classified as class IIb, unless the treatment for which the device is used consists of filtration, centrifugation or exchanges of gas, heat, in which case they are classified as class IIa.

All non-invasive devices consisting of a substance or a mixture of substances intended to be used in vitro in direct contact with human cells, tissues or organs taken from the human body or used in vitro with human embryos before their implantation or administration into the body are classified as class III.

Rule 4

All non-invasive devices which come into contact with injured skin or mucous membrane are classified as:

— class I if they are intended to be used as a mechanical barrier, for compression or for absorption of exudates;

— class IIb if they are intended to be used principally for injuries to skin which have breached the dermis or mucous membrane and can only heal by secondary intent;

— class IIa if they are principally intended to manage the micro-environment of injured skin or mucous membrane; and

— class IIa in all other cases.

This rule applies also to the invasive devices that come into contact with injured mucous membrane.

Invasive devices

Rule 5

All invasive devices with respect to body orifices, other than surgically invasive devices, which are not intended for connection to an active device or which are intended for connection to a class I active device are classified as:

— class I if they are intended for transient use;

— class IIa if they are intended for short-term use, except if they are used in the oral cavity as far as the pharynx, in an ear canal up to the ear drum or in the nasal cavity, in which case they are classified as class I; and

— class IIb if they are intended for long-term use, except if they are used in the oral cavity as far as the pharynx, in an ear canal up to the ear drum or in the nasal cavity and are not liable to be absorbed by the mucous membrane, in which case they are classified as class IIa.

All invasive devices with respect to body orifices, other than surgically invasive devices, intended for connection to a class IIa, class IIb or class III active device, are classified as class IIa.

Rule 6

All surgically invasive devices intended for transient use are classified as class IIa unless they:

— are intended specifically to control, diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with those parts of the body, in which case they are classified as class III;

— are reusable surgical instruments, in which case they are classified as class I;

— are intended specifically for use in direct contact with the heart or central circulatory system or the central nervous system, in which case they are classified as class III;

— are intended to supply energy in the form of ionising radiation in which case they are classified as class IIb;

— have a biological effect or are wholly or mainly absorbed in which case they are classified as class IIb; or

— are intended to administer medicinal products by means of a delivery system, if such administration of a medicinal product is done in a manner that is potentially hazardous taking account of the mode of application, in which case they are classified as class IIb.

Rule 7

All surgically invasive devices intended for short-term use are classified as class IIa unless they:

— are intended specifically to control, diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with those parts of the body, in which case they are classified as class III;

— are intended specifically for use in direct contact with the heart or central circulatory system or the central nervous system, in which case they are classified as class III;

— are intended to supply energy in the form of ionizing radiation in which case they are classified as class IIb;

— have a biological effect or are wholly or mainly absorbed in which case they are classified as class III;

— are intended to undergo chemical change in the body in which case they are classified as class IIb, except if the devices are placed in the teeth; or

— are intended to administer medicines, in which case they are classified as class IIb.

Rule 8

All implantable devices and long-term surgically invasive devices are classified as class IIb unless they:

— are intended to be placed in the teeth, in which case they are classified as class IIa;

— are intended to be used in direct contact with the heart, the central circulatory system or the central nervous system, in which case they are classified as class III;

— have a biological effect or are wholly or mainly absorbed, in which case they are classified as class III;

— are intended to undergo chemical change in the body in which case they are classified as class III, except if the devices are placed in the teeth;

— are intended to administer medicinal products, in which case they are classified as class III;

— are active implantable devices or their accessories, in which cases they are classified as class III;

— are breast implants or surgical meshes, in which cases they are classified as class III;

— are total or partial joint replacements, in which case they are classified as class III, with the exception of ancillary components such as screws, wedges, plates and instruments; or

— are spinal disc replacement implants or are implantable devices that come into contact with the spinal column, in which case they are classified as class III with the exception of components such as screws, wedges, plates and instruments.

Rule 9

All active therapeutic devices intended to administer or exchange energy are classified as class IIa unless their characteristics are such that they may administer energy to or exchange energy with the human body in a potentially hazardous way, taking account of the nature, the density and site of application of the energy, in which case they are classified as class IIb.

All active devices intended to control or monitor the performance of active therapeutic class IIb devices, or intended directly to influence the performance of such devices are classified as class IIb.

All active devices intended to emit ionizing radiation for therapeutic purposes, including devices which control or monitor such devices, or which directly influence their performance, are classified as class IIb.

All active devices that are intended for controlling, monitoring or directly influencing the performance of active implantable devices are classified as class III.

Rule 10

Active devices intended for diagnosis and monitoring are classified as class IIa:

— if they are intended to supply energy which will be absorbed by the human body, except for devices intended to illuminate the patient’s body, in the visible spectrum, in which case they are classified as class I;

— if they are intended to image in vivo distribution of radiopharmaceuticals; or

— if they are intended to allow direct diagnosis or monitoring of vital physiological processes, unless they are specifically intended for monitoring of vital physiological parameters and the nature of variations of those parameters is such that it could result in immediate danger to the patient, for instance variations in cardiac performance, respiration, activity of the central nervous system, or they are intended for diagnosis in clinical situations where the patient is in immediate danger, in which cases they are classified as class IIb.

Active devices intended to emit ionizing radiation and intended for diagnostic or therapeutic radiology, including interventional radiology devices and devices which control or monitor such devices, or which directly influence their performance, are classified as class IIb.

Rule 11

Software intended to provide information which is used to take decisions with diagnosis or therapeutic purposes is classified as class IIa, except if such decisions have an impact that may cause:

— death or an irreversible deterioration of a person’s state of health, in which case it is in class III; or

— a serious deterioration of a person’s state of health or a surgical intervention, in which case it is classified as class IIb.

Software intended to monitor physiological processes is classified as class IIa, except if it is intended for monitoring of vital physiological parameters, where the nature of variations of those parameters is such that it could result in immediate danger to the patient, in which case it is classified as class IIb.

All other software is classified as class I.

Rule 12

All active devices intended to administer and/or remove medicinal products, body liquids or other substances to or from the body are classified as class IIa, unless this is done in a manner that is potentially hazardous, taking account of the nature of the substances involved, of the part of the body concerned and of the mode of application in which case they are classified as class IIb.

Rule 13

All other active devices are classified as class I.

Special rules

Rule 14

All devices incorporating, as an integral part, a substance which, if used separately, can 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 devices, are classified as class III.

Rule 15

All devices used for contraception or prevention of the transmission of sexually transmitted diseases are classified as class IIb, unless they are implantable or long term invasive devices, in which case they are classified as class III.

Rule 16

All devices intended specifically to be used for disinfecting, cleaning, rinsing or, where appropriate, hydrating contact lenses are classified as class IIb.

All devices intended specifically to be used for disinfecting or sterilising medical devices are classified as class IIa, unless they are disinfecting solutions or washer-disinfectors intended specifically to be used for disinfecting invasive devices, as the end point of processing, in which case they are classified as class IIb.

This rule does not apply to devices that are intended to clean devices other than contact lenses by means of physical action only.

Rule 17

Devices specifically intended for recording of diagnostic images generated by X-ray radiation are classified as class IIa.

Rule 18

All devices manufactured utilising tissues or cells of human or animal origin, or their derivatives, which are non- viable or rendered non-viable, are classified as class III, unless such devices are manufactured utilising tissues or cells of animal origin, or their derivatives, which are non-viable or rendered non-viable and are devices intended to come into contact with intact skin only.

Rule 19

All devices incorporating or consisting of nanomaterial are classified as:

— class III if they present a high or medium potential for internal exposure;

— class IIb if they present a low potential for internal exposure; and

— class IIa if they present a negligible potential for internal exposure.

Rule 20

All invasive devices with respect to body orifices, other than surgically invasive devices, which are intended to administer medicinal products by inhalation are classified as class IIa, unless their mode of action has an essential impact on the efficacy and safety of the administered medicinal product or they are intended to treat life- threatening conditions, in which case they are classified as class IIb.

Rule 21

Devices that are composed of substances or of combinations of substances that are intended to be introduced into the human body via a body orifice or applied to the skin and that are absorbed by or locally dispersed in the human body are classified as:

— class III if they, or their products of metabolism, are systemically absorbed by the human body in order to achieve the intended purpose;

— class III if they achieve their intended purpose in the stomach or lower gastrointestinal tract and they, or their products of metabolism, are systemically absorbed by the human body;

— class IIa if they are applied to the skin or if they are applied in the nasal or oral cavity as far as the pharynx, and achieve their intended purpose on those cavities; and

— class IIb in all other cases.

Rule 22

Active therapeutic devices with an integrated or incorporated diagnostic function which significantly determines the patient management by the device, such as closed loop systems or automated external defibrillators, are classified as class III.

a) The device is intended by the manufacturer to measure

–

–

• quantitatively a physiological or anatomical parameter, or

Yes/No

• a quantity or a quantifiable characteristic of energy or of substances (including medicinal products) delivered to or removed from the human body. Spoons or plastic syringes co-packed with medicinal products and used to measure a quantity of that medicinal product to be administered to the patient are in this category. Devices for the delivery of liquid to the human body without graduation or scale (e.g. medicine spoons, cups, droppers without graduation or scale or display of measuring unit) are not in this category

Yes/No

b) The result of the measurement:

–

–

• is displayed in legal units or other acceptable units within the meaning of Directive 80/181/ECC20, or

Yes/No

• is compared to at least one point of reference indicated in legal units or other acceptable units in compliance with the mentioned directive

Yes/No

c) The intended purpose implies accuracy, claimed explicitly or implicitly, where a non-compliance with the implied accuracy could result in a significant adverse effect on the patient’s health and safety.

Yes/No

Notified Body Involvement

Tick the box via “◼”

◻ Yes

◻ No

Provide sufficient details to explain how the requirement is applicable or not applicable; provide the justification for the transitional provisions from MDD to MDR (if applicable); justify when the requirement will enter into force (if applicable); etc.

Quality management system

◻ Yes, per MDR Article 10(9)

◻ Yes, per EN ISO 13485

◻ Other

◻ N/A

Authorized representative

◻ Yes, per Articles 11 and 12

◻ N/A

Person Responsible for Regulatory Compliance

◻ Yes, per Article 15

◻ N/A

Declaration of conformity

◻ Yes, per Article 19 and Annex IV

◻ Yes, per Annex XIII

◻ N/A

CE marking

◻ Yes, per Article 20 and Annex V

◻ N/A

Technical documentation

◻ Yes, per Annexes II and III

◻ Yes, per Annex XIII

◻ N/A

Notified Body Opinion

◻ Yes, per Article 117

◻ N/A

Consultation procedure with EMA or CA

◻ Yes, the device includes a medicinal substance (Annex IX 5.2)

◻ Yes, the device includes tissues or cells of human/animal origin and their derivatives (Annex IX 5.3)

◻ Yes, the device includes substances absorbed by or locally dispersed in the human body (Annex IX 5.4)

◻ N/A

Clinical evaluation

◻ Yes, per Article 61 and Annex XIV

◻ N/A

Summary of safety and clinical performance

◻ Yes, per Article 32

◻ N/A

Expert panel review

◻ Yes, per Article 54

◻ No, within exemptions from Article 54.2

◻ N/A

Implant card

◻ Yes, per Article 18

◻ N/A

Post-market surveillance (PMS) activities

◻ Yes, per Articles 83 to 86 and Annex III

◻ N/A

Post-market clinical follow-up (PMCF) activities

◻ Yes, per Article 61 and Annex XIV

◻ N/A

UDI carrier

◻ Yes, per Annex VI Part C

◻ Yes, but applicable from YYYY/MM/DD per Article 123

◻ N/A

Basic UDI-DI, UDI-DI/PI

◻ Yes, per Article 27 and Annex VI

◻ N/A

Economic operator registration

◻ Yes, per Articles 30, 31, 120 and Annex VI

◻ N/A

Device registration

◻ Yes, per Articles 29, 120 and Annex VI

◻ N/A

Transitional provisions for legacy device

◻ Yes, per article 120

◻ N/A, the product is not a legacy device

Other

MDCG guidance documents

Check the applicable MDCG guidance documents via the following website.

MDCG 2020-2 rev.1

Class I transitional provisions under Article 120 (3 and 4) – (MDR)

Applicable to class I only

MDCG 2019-15 rev.1

Guidance notes for manufacturers of class I medical devices

Applicable to class I only

MDCG 2020-7

Guidance on PMCF plan template

Applicable to all devices

MDCG 2020-8

Guidance on PMCF evaluation report template

Applicable to all devices

MDCG 2022-21

Guidance on Periodic Safety Update Report (PSUR) according to Regulation (EU) 2017/745

Applicable to all devices

MDCG 2020-6

Guidance on sufficient clinical evidence for legacy devices

Applicable to all devices

MDCG 2020-5

Guidance on clinical evaluation – Equivalence

Applicable when an equivalence route is used in the CER

MDCG 2019-9 – Rev.1

Summary of safety and clinical performance

Applicable to class III and implantable devices

MDCG 2021-3

Questions and Answers on Custom-Made Devices

Applicable to custom made devices

MDCG 2021-11

Guidance on Implant Card – Device types

Applicable to implants

MDCG 2019-8 v2

Guidance document implant card on the application of Article 18 Regulation (EU) 2017/745 on medical devices

Applicable to implants

MDCG 2020-1

Guidance on clinical evaluation (MDR) / Performance evaluation (IVDR) of medical device software

Applicable to devices with software

MDCG 2019-16 rev.1

Guidance on cybersecurity for medical devices

Applicable to devices with software

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Harmonized standards

Consult the lists of harmonized standards via the following website

EN ISO 10993-23:2021

Biological evaluation of medical devices – Part 23: Tests for irritation [1]

Biocompatibility

EN ISO 11135:2014/A1:2019

Sterilization of health care products – Ethylene oxide – Requirements for the development, validation and routine control of a sterilization process for medical devices [2]

Sterilization

EN ISO 11137-1:2015/A2:2019

Sterilization of health care products – Radiation – Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices [3]

Sterilization

EN ISO 11737-2:2020

Sterilization of health care products – Microbiological methods – Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process [4]

Sterilization

25424:2019/A1:2022

Sterilisation of health care products – Low temperature steam and formaldehyde – Requirements for development, validation and routine control of a sterilisation process for medical devices [5]

Sterilization

EN ISO 10993-9:2021

Biological evaluation of medical devices – Part 9: Framework for identification and quantification of potential degradation products [6]

Biocompatibility

EN ISO 10993-12:2021

Biological evaluation of medical devices – Part 12: Sample preparation and reference materials [7}

Biocompatibility

EN ISO 11737-1:2018

Sterilization of health care products – Microbiological methods – Part 1: Determination of a population of microorganisms on products [8]

Sterilization

EN ISO 13408-6:2021

Aseptic processing of health care products – Part 6: Isolator systems [9]

Sterilization

EN ISO 13485:2016/A11:2021

Medical devices – Quality management systems – Requirements for regulatory purposes [10]

Quality management system

EN ISO 14160:2021

Sterilization of health care products – Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives – Requirements for characterization, development, validation and routine control of a sterilization process for medical devices [11]

Sterilization

EN ISO 15223-1:2021

Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements [12]

Labeling

EN ISO 17664-1:2021

Processing of health care products – Information to be provided by the medical device manufacturer for the processing of medical devices – Part 1: Critical and semi-critical medical devices [13]

Labeling

EN IEC 60601-2-83:2020/A11:2021

Medical electrical equipment – Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment [14]

Electrical equipment

EN 285:2015+A1:2021

Sterilization – Steam sterilizers – Large sterilizers [15]

Sterilization

EN ISO 14971:2019/A11:2021

Medical devices – Application of risk management to medical devices [16]

Risk management

EN ISO 10993-10:2023

Biological evaluation of medical devices – Part 10: Tests for skin sensitization [17]

Biocompatibility

State of the art standards

List additional standards relevant to the device that represent the state of the art (e.g. other biocompatibility standards, usability standards, etc.)

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