Clinical evaluation report

Clinical Evaluation Report

For

[Device Name]

Manufacturer Name: [Manufacturer name]

Document Number: XXXX

Revision: XXXX

Approval

Author Approval

Name:	Date:
Title:	Signature:

Evaluator Approval

Name:	Date:
Title:	Signature:
Name:	Date:
Title:	Signature:

Revision history

Table 1: History of revision

Revision	Date	Change History

Table of contents

Approval 2

Revision history 3

Table of contents 4

Acronyms and abbreviations 7

Executive summary 8

1. Scope of the Clinical Evaluation 10

1.1. Introduction 10

1.2. Manufacturer details 11

1.3. Notified Body (NB) details 11

1.4. Device(s) under evaluation 11

1.5. Device description 11

1.6. Intended purpose 13

1.6.1. Intended use statement 13

1.6.2. Indications for use statement 13

1.6.3. Intended clinical benefits 13

1.6.4. Target patient population 13

1.6.5. Intended User 13

1.6.6. Contraindications 13

1.6.7. Warning and precautions 13

1.6.8. Undesirable side-effects 13

1.6.9. Device lifetime 13

1.6.10. Use of pharmaceutical, non-viable animal or human tissues 13

1.7. Clinical benefits and claims 13

1.8. Device history and geographic distribution 14

1.9. Applicable general safety and performance requirements (GSPRs) 15

1.9.1. GSPR 1 15

1.9.2. GSPR 2 15

1.9.3. GSPR 4 15

1.9.4. GSPR 6 15

1.9.5. GSPR 8 15

1.10. Evaluator qualifications 16

1.11. Inputs/Outputs of data generated and held by the manufacturer 16

2. State of the art (SOTA) 16

2.1. Description of the state of the art (SOTA) 17

2.1.1. State of the art (SOTA) literature search strategy and appraisal 17

2.1.2. Historical context and development 18

2.1.3. Standards and guidance documents 18

2.1.4. Description of medical condition and prevalence 19

2.1.5. Targeted user 19

2.1.6. Device concept 19

2.1.7. Description of alternative treatments 19

2.1.8. Benefits, risks, advantages, and disadvantages of alternative treatments 20

2.1.9. Summary of recommendations from professional guidelines 22

2.2. Similar device 22

2.2.1. Summary and appraisal of clinical data on similar devices 23

2.2.2. Justification of safety and performance outcome parameters and acceptance criteria 32

2.3. Novelty & well-established technology 34

2.3.1. Novelty 34

2.3.2. Well-established technology (WET) 35

2.4. State of the art (SOTA) Conclusion 35

3. Device under evaluation 36

3.1. Equivalent device 36

3.1.1. Equivalent device description 36

3.1.2. Justification of equivalence 36

3.2. Level of clinical data required 39

3.2.1. Exemption of clinical investigation only applicable to class III and implantable devices 39

3.2.2. Determination of minimum level of clinical data required 39

3.3. Summary and appraisal of clinical data for S&P 42

3.3.1. Summary and appraisal of pre-clinical study 42

3.3.1. Summary and appraisal of clinical investigation 42

3.3.2. Summary and appraisal of PMCF specific procedure 47

3.3.3. Summary and appraisal of published clinical literature 51

3.3.4. Summary and appraisal of external PMS database 61

3.3.5. Summary and appraisal of SSCP clinical data of equivalent devices 63

3.3.6. Summary and appraisal of internal PMS data 66

3.3.7. Conclusion of available clinical data and appraisal 68

3.4. Clinical data analysis 68

3.4.1. Level of clinical evidence available 68

3.4.2. Safety evaluation (GSPR 1, 2, 3) 69

3.4.3. Acceptability of clinical risks and side-effects (GSPR 1, 8) 71

3.4.4. Performance evaluation (GSPR 1, 6) 71

3.4.5. Benefit/risk profile (GSPR 8) 74

4. Conclusion 77

5. References 78

Appendix A – Evaluator qualifications and declaration of interest 79

Appendix B – Appraisal criteria 80

Appendix C – Clinical/PMCF investigation protocols and reports 81

Appendix D – Clinical data search protocol 82

Appendix E – Literature search report for SOTA 83

Appendix F – Literature search report for acceptance criteria (AC) of S&P 84

Appendix G – Literature search report for S&P 85

Appendix H – Vigilance/recall search report 86

Appendix I – Existing literature and gap search report 87

Appendix J – Articles 88

Acronyms and abbreviations

AC	Acceptance criteria
ANSM	Agence nationale de sécurité du médicament et des produits de santé
Bfarm	Bundesinstitut für arzneimittel und medizinprodukte
B/R	Benefit/Risk
CAPA	Corrective action preventive action
CE	Conformitè europëenne
CEP	Clinical evaluation plan
CER	Clinical evaluation report
CI	Clinical investigation
CS	Common specifications
DAEN	Database of adverse event notifications
DoI	Declaration of interest
EMDN	European medical device nomenclature
EU	European union
FDA	Food and drug administration
FSCA	Field safety corrective action
GSPR	General safety and performance requirements
IFU	Instructions for use
LoE	Level of evidence
MAUDE	Manufacturer and user facility device experience
MDA	Active medical device
MDCG	Medical device coordinating group
MDD	Medical devices directive
MDN	Non-active medical device
MDR	Medical devices regulation
MEDDEV	Medical devices documents
MHRA	Medical and healthcare products regulatory agency
N/A	Not applicable
NB	Notified body
OPC	Objective performance criteria
PMCF	Post-market clinical follow-up
PMS	Post-market surveillance
PRISMA	Preferred reporting items for systematic reviews and meta-analyses
PSUR	Periodic safety update report
QMS	Quality management system
SARA	System for Australian recall actions
SOTA	State of the art
SRN	Single registration number
SSCP	Summary of safety and clinical performance
S&P	Safety and performance
TD	Technical documentation
TPLC	Total product life cycle
UDI	Unique device identification
UDI-DI	UDI-Device identifier
WET	Well-established technology

Executive summary

This document is the initial/an update of clinical evaluation report (CER) under (EU) 2017/745 (MDR) for [Device name] (hereafter named [Device short name]) manufactured by [manufacturer name] (hereafter named [manufacturer short name]), for the purpose of compliance to the general safety and performance requirements (GSPRs).

The device was previously CE marked under 93/42/EEC (MDD) as the device has been commercialized in the EU since YYYY.

[Device short name] is a sterile/non-sterile, single use/reusable, class I/Is/Im/Ir/IIa/IIb/III medical device indicated for XXX Copy the indication for use statement.

[Device short name] is XXXX Include a short device description.

The state of the art (SOTA) of the medical condition to be treated/diagnosed by [Device short name] has been established (see Section 2.1) and the alternative treatments and similar devices are the following:

• XXXX Target treatment
  • XXXX Similar device
  • XXXX Similar device
• XXXX Alternative treatment
• XXXX Alternative treatment

XXXX Include a summary of the conclusions that place the device within the treatment/diagnostic strategy of the medical condition.

A systematic clinical data search methodology has been developed to obtain a sufficient level of clinical evidence for the compliance to applicable GSPR for [Device short name]. The clinical evaluation is not based on the equivalence/is based on the equivalence with [Equivalent device name], manufactured by [equivalent device manufacturer name]. The following sources of clinical data have been included into the clinical evaluation:

• Premarket investigation: XX studies with a total number of Y patients
• Post-market clinical follow-up (PMCF) investigation: XX studies with a total number of Y patients
• Other PMCF activities: e.g., XXX survey received from Y patients/user
• Articles in the literature: XX articles with a total number of Y patients
• Post-market surveillance (PMS) activities: XXX sales over last Y years with WWW complaints received and ZZZ complaints reported to regulatory authorities.
• Preclinical data: [Device short name] complies with the of European harmonized, international or technical standards and Common Specifications (CS) recognized in Europe for the generic device type.

The safety and performance claims (see Section 3.4.4) as well as the clinical benefits (see Section 3.4.5) have been substantiated by sufficient clinical evidence and they met the acceptance criteria defined based on the SOTA.

As described in Section 3.4.2, all clinical risks identified in the clinical data collected have been mitigated as far as possible through the [Manufacturer short name]’s risk management process, and the clinical residual risks have been delineated in the instructions for use through warnings, precautions, contra-indications, and list of complications. All risks identified with a clinical impact (including side-effects) have been deemed acceptable in comparison to the SOTA, as indicated in Section 3.4.3. Finally, the overall benefit-risk profile of [Device short name] has been weighted in Section 3.4.5 and the available clinical data confirm that the risks are acceptable when weighed against the intended benefits and are compatible with a high level of health and safety protection, taking into account current knowledge and the SOTA.

The following table summarizes how the requirements from MDCG 2020-13 have been addressed in the CER.

Table 2: Traceability to requirements from clinical evaluation assessment report

CEAR Sections	Description	CER Sections
Section A: Administrative particulars (notified body, manufacturer, product and clinical evaluation report reference)	Medical device name model and type	Section 1.4
	Manufacturer(s) name and SRN	Section 1.2
	Notified body	Section 1.3
	Intended purpose	Section 1.6
	Check of clinical evaluation report authors	Section Approval and Appendix A – Evaluator qualifications and declaration of interest
	Source documents	Section 1.11
Section B: Reviewers involved in the notified body assessment of the clinical evaluation	N/A – requirements applicable to NBs
Section C: Device description, classification, clinical evaluation plan, information materials supplied by the manufacturer, acommon specifications and harmonised standards applied, equivalence and state of the art	Device description	Section 1.5
	Classification	Section 1.4
	Device configurations/variants	Section 1.5
	Accessories or compatible devices	Section 1.4
	Previous generations of the device	Section 2.1.2
	Similar devices	Section 2.2
	Clinical evaluation plan	Section 1.11
	Clinical performance, safety and benefit claims	Sections 1.7 and 2.2.1.3
	Residual risks and any undesirable side- effects	Sections 1.6.7 and 1.6.8
	Common specifications and harmonized standards applied	Section 2.1.3
	Demonstration of equivalence	Section 3.1.2
	Access of data	Section 3.1
	State of the art
	Benchmark devices, state of the art and other available treatment options	Section 2.1.7
	Safety, performance and benefit-risk claims – requirements in terms of the state of the art	Section 2.2.1.3
	Novelty	Section 2.3.1
Section D: Clinical literature review	Search criteria	Appendix D – Clinical data search protocol
	Selection criteria	Appendix D – Clinical data search protocol
	Literature search protocol
	a brief summary of the literature search strategy	Section 3.3.3
	systematic search and review methods	Appendix D – Clinical data search protocol
	Literature search documentation	Appendix D – Clinical data search protocol
	Data appraisal
	brief summary of data appraisal methods	Appendix B – Appraisal criteria
	appraisal results	Section 3.3.7
Section E: Clinical investigations and related documentation	Detail of premarket clinical investigation	Section 3.3.1
	Report of premarket clinical investigation	Section Appendix C – Clinical/PMCF investigation protocols and reports
	Detail of post-market clinical investigation	Section 3.3.2
	Clinical investigation plans	Section Appendix C – Clinical/PMCF investigation protocols and reports
Section F: PMS, PMCF and the plan for updates	Source documents	Section 1.11
	Justification for class III/implantable devices without CI (Article 61(4))	Section 3.2.1
	Justification for absence of planned PMCF	Section 4
	Clinical evaluation updates	Section 4
Section G: IFU, SSCP, labelling and other information supplied with the device	Source documents	Section 1.11
	Intended purpose	Section 1.6
	Intended patient population
	Intended users
	Limitations
	Contraindications
	Warnings and precautions
	Adequacy of IFU with S&P data from CER	Section 3.4.2
Section H: Summary of all available data and conclusions	CI on the device under evaluation	Section 3.3.1
	Equivalence data	Section 3.3.3
	Summary of safety	Sections 3.4.2 and 3.4.3
	Summary of performance	Section 3.4.4
	Sufficient level of evidence	Section 3.4.1
	Remaining questions	Section 3.4.5
Overall Conclusions	Benefit-risk conclusion	Section 3.4.5
	Justification of risks	Section 3.4.3
	Adequacy between risks and CER	Section 3.4.2
Section I: Clinical evaluation consultation procedure for certain class III and class IIb devices (Article 54)	N/A – requirements applicable to NBs – traceability to the results Section 1.11
Section J: Where demonstration of conformity based on clinical data is not deemed appropriate (Article 61[10])	Justification for reliance upon Article 61(10)	Section 3.2
	Non-clinical data (performance, bench, pre-clinical evaluation) available	Section 3.3.1
Section K: The voluntary clinical consultation on the clinical development strategy (Article 61[2])	Expert panel consultation reference	N/A – no consultation procedure performed
	Expert panel recommendations

Scope of the Clinical Evaluation

Introduction

The CER is performed to document [Device Short Name] meets the applicable GSPR for which clinical data are required. The clinical evaluation is intended to collect favorable and unfavorable clinical data related to [Device Short Name] and potential equivalent devices to support its safety and performance when used according to the manufacturer’s Instructions for Use (IFU) in a clinical setting taking into account the generally acknowledged SOTA. The clinical evaluation is conducted in compliance with MDR Article 61 and Annex XIV as well as the manufacturer’s clinical evaluation procedure [Doc], PMCF procedure [Doc] and clinical evaluation plan (CEP) [Doc + Rev].

The clinical evaluation has been performed according to the following requirements:

• Article 61 and Annex XIV of (EU) 2017/745 (MDR)
• MEDDEV 2.7/1, Rev 4 (June 2016)
• MDCG 2019-15 rev.1 (December 2019) For class I only (remove, if not applicable)
• MDCG 2020-1 (March 2020) For software only ( remove, if not applicable)
• MDCG 2020-5 (April 2020) When equivalence is used (remove, if not applicable)
• MDCG 2020-6 (April 2020)
• MDCG 2024-10 (June 2024), For orphan devices only (remove, if not applicable)

Manufacturer details

Table 3: Manufacturer information

Manufacturer name:
Manufacturer address:
SRN:

Notified Body (NB) details

Table 4: NB information

NB name:
NB address:
Email contact:
Contact phone number:
NB number:

Device(s) under evaluation

The device(s) in the scope of the clinical evaluation as described in the following table, is/are currently covered by the EU/CE Certificate under MDR/MDD (XXXXX).

OR

The device(s) in the scope of the clinical evaluation as described in the following table, have not yet been commercialized in the EU.

Table 5: Device(s) under evaluation

Device Trade Name
Medical device(s)
Model Number	Basic UDI-DI	Description	EMDN Code	MDN Code	Class	Rule
Accessory for medical device(s)

Justify the bundling of devices in a single CER

Device description

The [Device Short name] is a Include a general description (Sourced from the TD)

The [Device Short name] is intended for Include intended use (Sourced from the IFU)

The [Device Short name] consists of Include mode of action (Sourced from the TD)

The [Device Short name] is illustrated in the following Figure(s):

Figure 1: [Device Short Name]

XXX

The following tables describe the general device characteristics of [Device Short name]. (Sourced from the TD)

Table 6: General device characteristics

Materials:
Sterility:
Main Mechanical characteristics:
Main Physicochemical characteristics:
Invasiveness:
Nature of contact: Identification of organs, tissues or body fluids contacted by the device
Duration of use/nature of contact with the body:
Other

The [Device Short name] is available in a single model/various models for which the critical technical characteristics are the following:

Table 7: Critical device characteristics

Device Model	…	…		…	…	…

Flag the special characteristics (that are critical and not common to all models) for which specific clinical evidence shall be collected in the CER (e.g., extreme sizes in the range, multiple indications, multiple populations, configurations):

Sufficient clinical evidence needs to cover the intended purpose as described in Section 1.6 considering the indication(s), targeted patient(s), environment(s) of use, intended user(s), etc. Hence, the clinical evaluation will collect clinical evidence specific to the following intended use characteristics:

• XXXX Describe the critical characteristics of the intended purpose that needs to be substantiated by clinical data: e.g., indications (especially if multiple indications are claimed), patients (especially if there are multiple type of patients, e.g., pediatric, adult), the environment of use (e.g., ICU, home, etc.), the users (nurses, qualified surgeon, etc.), etc.

In addition, sufficient clinical evidence needs to cover all common device characteristics as well as specific device characteristics that are considered critical for the safety and performance of [device short name]. Those characteristics include:

• E.g., Round and square shapes
• E.g., Non-sterile/sterile devices
• E.g., Extreme sizes of the device range
• E.g., Animal tissue
• E.g., Models with specific connections

For configurable devices only. Finally, the subject device is composed of components that can be configured in multiple combinations. The possible configurations are described below with the justification of the critical ones that are representative of all combinations and will be clinically evaluated:

• XXX

Intended purpose

Intended use statement

As specified in the IFU

Indications for use statement

As specified in the IFU

Intended clinical benefits

As specified in the IFU. Remove this section if not applicable.

Target patient population

As specified in the IFU

Intended User

As specified in the IFU

Contraindications

As specified in the IFU

Warning and precautions

As specified in the IFU

Undesirable side-effects

As specified in the IFU

Device lifetime

As specified in the IFU/TD

Use of pharmaceutical, non-viable animal or human tissues

As specified in the IFU/TD

Clinical benefits and claims

The clinical benefits as well as the claims of safety and performance for [Device Short Name] are presented in the following table.

Table 8: Clinical benefits and claims

Claims	Clinical claims	Non-clinical claims	Justification
Benefits (Section 1.6.3)
	X
		X
Performance
	X
		X
Safety
	X
		X

Section 3.4.4 and Section 3.4.5 describe respectively how the data that support the S&P claims and the clinical benefits are met.

Device history and geographic distribution

[Device Short Name] is a legacy/MDR device marketed in the EU under 93/42/EEC/(EU) 2017/745 since XXXX and has transitioned to MDR on DD/MM/YYYY.

Following the first commercialization/Since compliance to the MDR, the device has been modified several times as shown in the table below.

Table 9: History of changes

Design Change Number	Date of Implementation	Description	Clinical Impact

The changes identified in bold are those implemented since the last revision of the CER. As described, the clinical data collected before the implementation of changes are still applicable to the current [Device Short Name].

The following table represents the sales as well as the estimated number of uses in the countries or regions in which the device is commercialized including the year of first commercialization.

Table 10: Geographic repartition of sales

Country/Region	Year of first commercialization	Sale	Number of uses

The following table describes the sales as well as the estimated number of uses per device model with the year of first commercialization.

Table 11: Sales per device model

Device models	Year of first commercialization	Sale	Number of uses

Applicable general safety and performance requirements (GSPRs)

Per Article 61, at least GSPRs 1 and 8 are required. Include solely the applicable GSPRs as identified in the GSPR checklist.

GSPR 1

Devices shall achieve the performance intended by their manufacturer and shall be designed and manufactured in such a way that, during normal conditions of use, they are suitable for their intended purpose. They shall be safe and effective and shall not compromise the clinical condition or the safety of patients, or the safety and health of users or, where applicable, other persons, provided that any risks which may be associated with their use constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety, taking into account the generally acknowledged state of the art.

GSPR 2

The requirement in this Annex to reduce risks as far as possible means the reduction of risks as far as possible without adversely affecting the benefit-risk ratio.

GSPR 4

Risk control measures adopted by manufacturers for the design and manufacture of the devices shall conform to safety principles, taking account of the generally acknowledged state of the art. To reduce risks, Manufacturers shall manage risks so that the residual risk associated with each hazard as well as the overall residual risk is judged acceptable. In selecting the most appropriate solutions, manufacturers shall, in the following order of priority:

1. eliminate or reduce risks as far as possible through safe design and manufacture;
2. where appropriate, take adequate protection measures, including alarms if necessary, in relation to risks that cannot be eliminated; and
3. provide information for safety (warnings/precautions/contra-indications) and, where appropriate, training to users.

Manufacturers shall inform users of any residual risks.

GSPR 6

The characteristics and performance of a device shall not be adversely affected to such a degree that the health or safety of the patient or the user and, where applicable, of other persons are compromised during the lifetime of the device, as indicated by the manufacturer, when the device is subjected to the stresses which can occur during normal conditions of use and has been properly maintained in accordance with the manufacturer’s instructions.

GSPR 8

All known and foreseeable risks, and any undesirable side-effects, shall be minimised and be acceptable when weighed against the evaluated benefits to the patient and/or user arising from the achieved performance of the device during normal conditions of use.

Evaluator qualifications

[Manufacturer Short Name] has identified the following requirements for the evaluator(s):

• A degree from higher education in the respective field and five years of documented professional experience; or
• Ten years of documented professional experience if a degree is not a prerequisite for a given task.

The evaluator’s qualifications as well as the Declaration of Interest (DoI) are included in Appendix A – Evaluator qualifications and declaration of interest

Inputs/Outputs of data generated and held by the manufacturer

The following documents generated by [Manufacturer Short Name] are inputs or outputs of the CER.

Table 12: Documents of reference (remove when not applicable)

Documents	Document Number	Input	Output	Comments
Instructions for use	Doc + Rev	X	X
Risk management file	–	–	–	–
Risk management plan	Doc + Rev	X	–
Risk analysis	Doc + Rev	X	X
Risk management report	Doc + Rev	X	X
Clinical evaluation plan (CEP)	Doc + Rev	X	–
PMCF Evaluation Report	Doc + Rev	X	–
PSUR/PMS report	Doc + Rev	X	–
PMCF Plan	Doc + Rev	–	X
PMS Plan	Doc + Rev	–	X
Technical Documentation (TD)	Doc + Rev	X	X
Summary of safety and clinical performance (SSCP)	Doc + Rev	–	X
Expert panel consultation reference	Doc + Rev	X	–

The documents are available in the [Manufacturer Short Name]’s QMS and available under request.

In case of expert panel consultation procedure by manufacturer, describe the recommendation in this section.

State of the art (SOTA)

A literature search strategy has been carried out to establish the current SOTA of the medical conditions for which [device short name] is intended to be used. The strategy has been defined in the clinical data search protocol [Doc+Rev] and implemented in the literature search reports for SOTA, [Doc+Rev], and for safety and performance (S&P) acceptance criteria (AC), [Doc+Rev], respectively in Appendix D – Clinical data search protocol, Appendix E – Literature search report for , Appendix F – Literature search report for acceptance criteria.

The clinical evaluation is defined based on a methodologically sound procedure that also aims at providing a list of parameters and specifications to determine, based on the SOTA, the acceptability of the benefit-risk profile for [device short name]. As a result, Section 2.1 summarizes the key information from the SOTA of medical conditions for which [device short name] is intended to be used and Section 2.2 the clinical benefits, performance and safety outcome parameters and specifications defined based on similar devices/and therapeutic alternatives.

Description of the state of the art (SOTA)

State of the art (SOTA) literature search strategy and appraisal

The implementation of published literature searches resulted in the inclusion of XX published articles with the objective to establish the SOTA (Objective 1) as described in Appendix E – Literature search report for .

The following figure describes the selection process used.

Figure 2: Literature search results for SOTA

Total Number of results

n=

Number of results without duplicates

n=

Number of results after Level 1 screening:

n=

Number of results after Level 2 screening:

n=

Figure to be completed as necessary.

All clinical evidence collected to describe the SOTA has been evaluated Rank 6 per the appraisal criteria defined in Appendix B – Appraisal criteria.

Historical context and development

To be defined based on the literature articles included for the SOTA.

Standards and guidance documents

To be defined based on the literature articles included for the SOTA.

Standards

Align the list of standards with TD (maintain consistency within all clinical documents). The following table describes the specific design and test standards recognized for the specific technology used with [Device short name].

Table 13: List of recognized standards

Standard	version	Title
EN ISO 10993-1	2020	Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process
EN ISO 10993-5	2009	Biological evaluation of medical devices – Tests for in vitro cytotoxicity
EN ISO 10993-10	2021	Biological evaluation of medical devices – Tests for skin sensitization
EN ISO 10993-18	2020	Biological evaluation of medical devices – Chemical characterization of medical device materials within a risk management process
EN ISO 10993-23	2021	Biological evaluation of medical devices – Tests for irritation
EN ISO 14971	2019+A11:2021	Medical devices – Application of Risk Management to Medical Devices
EN 62366-1	2015+A1:2020	Medical devices – Application of usability engineering to medical devices

Guidance documents

To be defined based on the literature articles included for the SOTA.

The following table describes the professional guidelines recognized for the specific technology used with [Device short name].

Table 14: List of professional guidelines

Reference	version	Title

Description of medical condition and prevalence

To be defined based on the literature articles included for the SOTA.

Targeted user

To be defined based on the literature articles included for the SOTA.

Device concept

To be defined based on the literature articles included for the SOTA.

Description of alternative treatments

To be defined based on the literature articles included for the SOTA.

Benefits, risks, advantages, and disadvantages of alternative treatments

To be defined based on the literature articles included for the SOTA.

The benefits, risks, advantages, and disadvantages of all available alternative treatment options identified from

the SOTA literature, are presented in the following table.

Table 15: Benefits, risks, advantages, and disadvantages of treatment options

Treatment options	Benefits (B)	Risks (R)	Advantages (A)	Disadvantages (D)

For devices for which the placement in the treatment strategy is not established in guidelines or is not clear, the following table is more suitable for a clear comparison by criteria.

B/R parameters		Targeted treatment	Alternative 1	Alternative 2	…
BRAD	Criteria
Benefits (B)
Risks (R)
Advantages (A)
Disadvantages (D)

Summary of recommendations from professional guidelines

To be defined based on the literature articles included for the SOTA.

Similar device

As part of the therapeutic alternatives, the following devices have been considered similar to [Device Short Name]. They have been deemed similar as they do not meet the clinical, technical and biological criteria as detailed in Annex XIV section 3 of the MDR but share a similar device technology under the same EMDN code and are intended to be used for the same indication and patient’s medical conditions, in the same environment and by the same type of user.

Table 16: Similar devices

Similar devices	Manufacturer Name
[similar device 1]
[similar device 2]
…

Optional As the parameters and specifications for the clinical benefits, safety and performance of [device short name] cannot be established solely based on similar devices, [Manufacturer short name] also considered the following therapeutic alternatives:

• XXX
• XXX

Description of [similar device 1]

Include a general description

A comparison between [device short name] and [similar device 1] is presented in the table below per the criteria described in MDCG 2020-5. A simplified version of the comparison table would also be acceptable.

Table 17: Comparison between [device short name] and [similar device 1]

Critical characteristics	Subject device	Similar device
Device Name	[device short name]	[similar device 1]
Device Manufacturer	[manufacturer short name]
CE marking
Clinical criteria
Intended purpose/indication for use
Clinical conditions
Disease treated (including severity/stage)
Application site
Patient population
User
Relevant clinical performance in view of expected clinical effect
…
Technical criteria
Design characteristics (shape, size, etc.)
Physico-chemical properties (e.g. strength, viscosity)
Principle of use (e.g. deployment)
…
Biological criteria
Body Contact
Material or substances
Duration of body contact
Release characteristics of substances (degradation product, leachable)
…

Description of [similar device 2]

Include a general description

A comparison between [device short name] and [similar device 2] is presented in the table below per the criteria described in MDCG 2020-5. A simplified version of the comparison table would also be acceptable.

Table 18: Comparison between [device short name] and [similar device 2]

Critical characteristics	Subject device	Similar device
Device Name	[device short name]	[similar device 2]
Device Manufacturer	[manufacturer short name]
CE marking
Clinical criteria
Intended purpose/indication for use
Clinical conditions
Disease treated (including severity/stage)
Application site
Patient population
User
Relevant clinical performance in view of expected clinical effect
…
Technical criteria
Design characteristics (shape, size, etc.)
Physico-chemical properties (e.g. strength, viscosity)
Principle of use (e.g. deployment)
…
Biological criteria
Body Contact
Material or substances
Duration of body contact
Release characteristics of substances (degradation product, leachable)
…

Summary and appraisal of clinical data on similar devices

Summary and appraisal of published and non-published clinical literature

The implementation of literature searches resulted in the inclusion of XX published articles with the objective to establish the safety and performance profile of similar devices/alternative treatment (objective 2) as described in Appendix F – Literature search report for acceptance criteria.

Figure 3: Literature search results for similar devices

Total Number of results

n=

Number of results without duplicates

n=

Number of results after Level 1 screening:

n=

Number of results after Level 2 screening:

n=

Figure to be completed as necessary.

The S&P information relevant to similar devices and/or therapeutic alternatives is summarized and appraised in the following table to establish their current safety and performance profiles.

The following table describes the study information, device and demographic characteristics for the articles specific to similar devices/therapeutic alternatives for the purpose to establish the acceptance criteria of safety and performance.

Table 19: Summary of published clinical literature used to establish the acceptance criteria

Article	Study type	Device characteristics		Indication	Number of patients	Demographic characteristics		Follow-up
		Device Name	Size			Age	Sex

All articles have been appraised per the requirements described in Appendix B – Appraisal criteria. The following table describes the results of appraisal process:

Table 20: Appraisal of articles used to define the S&P AC

Article ref	MDCG 2020-6	Oxford LoE	Suitability				Contribution
			D	A	P	R	T	O	F	S	C

Safety outcome parameters related to similar devices

The safety outcome parameters and specifications as discussed in the literature on similar devices/therapeutic alternatives are described in the following table.

Table 21: Summary of safety outcome parameters to establish the acceptance criteria

Article ref.	Safety outcome parameters	Results			Comments
		Device	Timepoint	Specification

Performance outcome parameters related to similar devices

The performance outcome parameters and specifications as discussed in the literature on similar devices/therapeutic alternatives are described in the following table.

Table 22: Summary of performance outcome parameters to establish the acceptance criteria

Article ref.	Performance outcome parameters	Results			Comments
		Device	Timepoint	Specification

Clinical risks reported with similar devices

The following table describes the clinical risks identified in the articles collected on similar devices/therapeutic alternatives

Table 23: Summary of clinical risks to establish the acceptance criteria

Article ref.	Clinical risks	Results			Comments
		Device	Timepoint	Rate

Summary and appraisal of external PMS database

Optional – This section can be useful when there is insufficient information in the literature to establish the acceptance criteria. E.g., generic devices, ancillary devices.

A search in vigilance and recall databases has been conducted to retrieve the clinical risks related to devices similar to [Device Short Name] (Objective 2). For the period from DD-MM-YYYY to DD-MM-YYYY, a total of XX vigilance and XX FSCA have been retrieved in the external PMS database consulted for the devices similar to [Device Short Name].

The protocol is available in Appendix D – Clinical data search protocol, and the report in Appendix F – Literature search report for acceptance criteria.

The results are appraised with a Rank 7 according to the criteria described in Appendix B – Appraisal criteria.

The following table presents the number of relevant events retrieved for all databases consulted.

Table 24: Results of vigilance/recall search implementation of similar devices

Database	Objective	Vigilance/recall search report	Number of results:				Event type			FSCA
			Total	Excluded	Duplicate	Included	Device-related	Patient-related	Death
FDA MAUDE	2
	2
FDA Medical Device Recalls	2
	2
FDA TPLC	2
	2
ANSM safety information	2
	2
Bfarm Field Corrective Actions	2
	2
MHRA Alerts, recalls and safety information: drugs and medical devices	2
	2
SwissMedic – FSCA and recall	2
	2
DAEN (Database of Adverse Event Notifications) – medical devices	2
	2
SARA (System for Australian Recall Actions)	2
	2
Canadian recalls and safety alerts	2
	2
TOTAL

The PMS review identified clinical risks and undesirable side-effects related to devices similar to [Device Short Name] as reported in the following table.

Table 25: Risks from public vigilance and recall databases

Events Reported	Event types	Occurrence
		Similar device 1	Similar device 2	Similar device 3
Device-related risks
Patient-related risks (including undesirable Side-Effect)

Summary and appraisal of SSCP clinical data

Only applicable to class III and implantable devices

For MDR class III and implantable devices, manufacturers are required to make publicly available the summary of safety and clinical performance (SSCP) via EUDAMED. Until EUDAMED becomes fully functional, SSCPs may be found on the websites of manufacturers or in other public locations.

A search has been implemented to find the SSCPs of MDR devices similar to [device short name] starting from EUDAMED and manufacturer websites.

The result of the search has been extracted to ensure the characterization of safety and performance of similar devices. The following SSCPs have been retrieved:

Table 26: Impact assessment of SSCP clinical data on similar devices

Similar device	Document number	Link to SSCP
XXXX (similar device)
XXXX (similar device)

The following table describes the study information, device and demographic characteristics for SSCP clinical data specific to similar devices for the purpose of establishing their safety and performance profile.

Table 27: Summary of published clinical SSCP clinical data on similar devices

Title of clinical data	SSCP clinical data type	Device characteristics		Indication	Number of patients	Demographic characteristics		Follow-up
		Device Name	Size			Age	Sex

All articles have been appraised per the requirements described in Appendix B – Appraisal criteria. The following table describes the results of appraisal process:

Table 28: Appraisal of SSCP clinical data on similar devices

Clinical data ref	MDCG 2020-6	Oxford LoE	Suitability				Contribution
			D	A	P	R	T	O	F	S	C

Safety outcome parameters related to similar devices

The safety outcome parameters and specifications as discussed in the SSCP clinical data on similar devices are described in the following table.

Table 29: Summary of safety outcome parameters on similar devices

Clinical data ref.	Safety outcome parameters	Results			Comments
		Device	Timepoint	Specification

Performance outcome parameters related to similar devices

The performance outcome parameters and specifications as discussed in the SSCP clinical data on similar devices are described in the following table.

Table 30: Summary of performance outcome parameters on similar devices

Article ref.	Performance outcome parameters	Results			Comments
		Device	Timepoint	Specification

Clinical risks reported with similar devices

The following table describes the clinical risks identified in the SSCP clinical data collected on similar devices.

Table 31: Summary of clinical risks on similar devices

Article ref.	Clinical risks	Results			Comments
		Device	Timepoint	Rate

Justification of safety and performance outcome parameters and acceptance criteria

Further to the review of SOTA as described in Section 2.2.1, the following safety and performance outcome parameters have been considered relevant for the evaluation of S&P of [Device Short Name]:

Table 32: Retained S&P acceptance criteria

[Manufacturer short name]’s claims	Outcome parameters selected	Acceptance criteria
Safety
Performance
Benefit

Include a justification for the selection of safety outcome parameters, performance outcome parameters, benefit outcome parameters and the associated acceptance criteria. The justification can be based on:

• How those parameters are relevant, and/or
• How the other parameters are not relevant
• Etc.

Novelty & well-established technology

Novelty

The novelty of [Device short name] has been evaluated for the criteria evaluated critical regarding safety and performance of the device with the consideration of clinical, technical and biological criteria as defined in Annex XIV of the MDR and described in the following table.

Table 34: Justification of novelty

Critical device characteristics	Any Novelty?	Description of novelty or justification for absence of novelty	Clinical impact of any novelty
Clinical characteristics
Medical purpose	Yes/No	If yes, specifically describe novel features If no, provide evidence/justification to demonstrate non-novel features (e.g., based on similar devices)	If yes, describe the clinical impact and how this will be addressed in the CER If no, indicate N/A – no novelty
Indications for use
Targeted type of procedure
Principles of operations
Condition of use
Targeted patients
Targeted users
Environment of use
Deployment Methods
…
Technical characteristics
Design characteristics (e.g., shape, size, components)
Design characteristics (e.g., shape, size, components)
Mechanism of action
Device-Patient Interface
Compatibility with other devices
Manufacturing process
…
Biological characteristics
Materials
Site of application
Duration of contact
…

No novelty has been defined with [Device short name].

OR

The device includes the following novelty according to the current SOTA:

• XXXX
• XXXX
• XXXX

The novelty brought with [Device short name] has a significant/non-significant clinical impact because XXXX Include a summary the clinical impact of the novelty and how this will be addressed in the CER.

Well-established technology (WET)

This section can be removed if the device does not meet the WET definition

MDCG 2020-6 defines a WET as a device in the category listed in Article 61(6b) as amended by Delegated Acts (Article 61(8)). The list currently includes sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips or connectors.

[Device short name] meets the definition of WET and is recognized as a device:

• with relatively simple, common and stable designs with little evolution.

Include the rationale

• with well-known clinical performance characteristics

Include the rationale

• with a long history on the market

Include the rationale

• belonging to a generic device group:
  • with a well-known safety not associated with safety issues in the past

Include the rationale

• • recognized standard of care devices where there is little evolution in indications and the SOTA.

Include the rationale

Conclusion for WET device

[Device short name] is part of the WET devices described in Article 61(6b) and meets the WET criteria in the definition of MDCG 2020-6. Hence the cumulative evidence from Rank 5 to Rank 12, including Rank 6 (i.e., clinical data (based on SOTA) can be used to support the safety and performance of [Device short name]).

/OR

Conclusion for devices that are not in WET list but meet the definition.

Though [Device short name] is not part of the WET devices described in Article 61(6b), [Device short name] meets the WET definition described in MDCG 2020-6. Hence, the device is recognized in the current treatment strategy as defined in the SOTA for the treatment/diagnosis of XXXX Indicate the medical condition to be treated/diagnosed.

State of the art (SOTA) Conclusion

Include a summary of SOTA with the positioning of the device type within the landscape of treatment options

Device under evaluation

Equivalent device

To support the safety and performance of [device short name], [manufacturer short name] has decided to consider a route of equivalence per MDR Article 61(5) with [Equivalent device name] manufactured by [Equivalent device manufacturer name]. [Equivalent Device Name] meets the criteria defined in Annex XIV section 3 of the MDR and [Manufacturer Short name] has a sufficient access to the data related [Equivalent Device Name] in order to justify the claims of equivalence as identified in Table 35.

The access of data to support the equivalence is granted through XXXX describe the method of access to data

As [device short name] is a class III/or implantable device and the equivalent device (certified under MDR) is not manufactured by [manufacturer short name], an agreement [Doc+Rev] has been signed between [manufacturer short name] and [equivalent device manufacturer name] to give full access to the technical documentation of [equivalent device name] on an ongoing basis. For class III/implantable devices only

/OR

No equivalence to other devices has been claimed for the demonstration of safety and performance of [device short name]. Remove the next subsections if no equivalence route is used.

Equivalent device description

Equivalent device description

The following figure represents the [Equivalent Device Name]

Figure 4: Representative pictures of equivalent device

Justification of equivalence

The following table considers the critical relevant characteristics for the purpose of comparing [Device Short Name] and its equivalent device based on clinical, technical and biological criteria as established in Annex XIV section 3 of the MDR and MDCG 2020-5.

Table 35: Justification of equivalence

Characteristics	[Device Name]	[Equivalent device name]	Level of access for data on equivalent device	Identified differences or conclusion that there are no differences in the characteristic
Manufacturer Name	[Manufacturer short name]	[Equivalent device short name]	N/A	N/A
Picture			N/A	N/A
CE marking
Technical characteristics
Indicate the critical design characteristics				No differences in the characteristic OR short summary of the difference (refer to 1.X)
Condition of use
Indicate the critical specifications/technical features
Principles of operation
Deployment method
Critical performance requirements
Other
Scientific justification why there would be no clinically significant difference in the safety and clinical performance of the device, OR a description of the impact on safety and or clinical performance				Clinically significant difference Yes/No
1.1.
1.2.
Biological characteristics
Materials in contact with the human tissue/body				No differences in the characteristic OR short summary of the difference (refer to 2.X)
Duration of contact
Other (e.g., degradation characteristics if applicable)
Scientific justification why there would be no clinically significant difference in the safety and clinical performance of the device, OR a description of the impact on safety and or clinical performance				Clinically significant difference Yes/No
2.1.
2.2.
Clinical characteristics
Medical condition				No differences in the characteristic OR short summary of the difference (refer to 3.X)
Site in the body
Indication for use
Targeted patients
Intended users
Indicate the critical performances with a medical effect
Scientific justification why there would be no clinically significant difference in the safety and clinical performance of the device, OR a description of the impact on safety and or clinical performance				Clinically significant difference Yes/No
3.1.
3.2.
Summary
In the circumstance that more than one non-significant difference is identified, provide a justification whether the sum of differences may affect the safety and clinical performance of the device.

The characteristics listed above are identical or similar to the extent that there would be no clinically significant difference in the safety and clinical performance of the device.

[Device Short name] and [Equivalence Device Name] are considered equivalent for the purpose of this CER.

Level of clinical data required

Exemption of clinical investigation only applicable to class III and implantable devices

Legacy device

[Device short name] is transitioning to the MDR but was lawfully placed on the market in accordance to the MDD. No common specifications have been published for the clinical evaluation of [device short name]/OR This CER has been defined based on the common specifications applicable to [device short name]. Finally, the clinical data currently available on [Device short name] are assumed to be sufficient and the conclusion of the CER will confirm this assumption.

As a result, according to Article 61(6a) of the MDR, no clinical investigation is evaluated required as long as there is sufficient clinical evidence on [device short name] to comply with the applicable GSPRs.

WET device

[Device short name] is considered to be a WET device as it meets the definition from MDCG 2020-6 as described in Section 2.3.2 and is part of the list of WET in Article 61(6b) of the MDR. No common specifications have been published for the clinical evaluation of [device short name]/OR This CER has been defined based on the common specifications applicable to [device short name]. Finally, the clinical data currently available for the GSPR compliance of [Device short name] are assumed to be sufficient and the conclusion of the CER will confirm this assumption.

As a result, according to Article 61(6b) of the MDR, no clinical investigation is evaluated required as long as there is sufficient clinical evidence to comply with the applicable GSPRs.

Equivalent device with the same manufacturer

[Device short name] has been design by modifications of a device manufactured by [manufacturer short name] and both are considered equivalent per requirements from MDCG 2020-5 as described in Section 3.1.2. As a result [manufacturer short name] has defined a specific PMCF procedure to confirm the safety and performance of [Device short name] (see PMCF plan referenced in Section 1.11).

In conclusion, according to Article 61(4) of the MDR, no clinical investigation is evaluated required as long as there is sufficient clinical evidence on [Equivalent device name] to support the compliance of [device short name] with the applicable GSPRs.

Equivalent device with another manufacturer

As described in Section 3.1.2, [device short name] has been demonstrated to be equivalent to [Equivalent device name] not manufactured by [manufacturer short name] and currently commercialized in compliance to the MDR. Section 3.1 provides the details of the contract in place that allows the [manufacturer short name] full access to the technical documentation of [Equivalent device name] on an ongoing basis.

As a result, according to Article 61(5) of the MDR, no clinical investigation is evaluated required as long as there is sufficient clinical evidence on [Equivalent device name] to support the compliance of [device short name] with the applicable GSPRs.

Determination of minimum level of clinical data required

When article 61(10) applies

Article 61(1) of the MDR requires [Manufacturer short name] to justify the sufficient level of clinical evidence required to support the compliance to applicable GSPR. Using the criteria of Article 61(10), clinical data for [Device short name] were not deemed appropriate for the demonstration of conformity to GSPRs. The following table describes the justification drawn up by [Manufacturer short name]:

Table 36: Justification for meeting the criteria of Article 61(10)

Article 61(10) criteria	Justification	Conclusion
Results of the manufacturer’s risk management	Verify the possible patient harms for the risks identified in the risk analysis to verify if they need to be monitor by clinical data or preclinical data are sufficient. The approach is not acceptable for class III or implantable devices	[Device short name] is a class I/Is/Im/Ir/IIa/IIb non-implantable device. The risks resulting from the risk management activities are technical by nature and does not need to be substantiated by clinical data.
Interaction between the device and the human body	Devices without patient contact do not require clinical data. For devices with a limited contact (nature + duration), the rationale shall be discussed for the clinical significance and need (or no need) of clinical evidence. (E.g., justification difficult for a contact lense, devices in direct contact with blood or brain; justification possible for transient contact such as with scalpel for which the interaction should not have a clinical impact).	The interaction between the device and patients have been analyzed, are non-clinically significant and can be substantiated by non-clinical data.
Clinical performance intended	All performances and benefits shall be reviewed to confirm they are technical by nature and should not be verified with clinical data.	The review of performances claimed by the manufacturer did not emphasis any clinical performances leading to clinical benefits. All performances are technical by nature and does not need to be substantiated by clinical data
Claims of the manufacturer	All claims shall be reviewed to verify they can be achieved with preclinical data. E.g., claims for reduction of pain, surgery time, complications are not technical by nature. Claims for using a specific technology, compliance with preclinical standard, sterility, compatibility with MRI, … can be substantiated with preclinical data.	[Manufacturer short name] does not have any claim / does not have any claim that needs to be substantiated by clinical data. All claims are technical by nature.

If the rationale needs a long elaboration, the tabular format can be removed to include bullet points.

In conclusion, per the MDCG 2020-6 guidance document and considering [Device short name] meets the article 61(10) criteria, the minimum level of clinical evidence required will be from Rank 10 to 12, as applicable, with Rank 10 if common specifications have been published, with Rank 11 if preclinical tests with healthcare professionals/users are deemed required and Rank 12 for bench testing.

When article 61(10) does not apply

Article 61(1) of the MDR requires [Manufacturer short name] to justify the sufficient level of clinical evidence required to support the compliance to applicable GSPR. As described in the following table, MDCG 2020-6 Appendix III provides a suggested hierarchy of clinical evidence for the confirmation of conformity with applicable GSPRs under MDR.

Table 37: Hierarchy of clinical evidence under the MDR

Rank	Types of clinical data and evidence
1	Results of high-quality clinical investigations covering all device variants, indications, patient populations, duration of treatment effect, etc
2	Results of high-quality clinical investigations with some gaps
3	Outcomes from high quality clinical data collection systems such as registries
4	Outcomes from studies with potential methodological flaws but where data can still be quantified and acceptability justified
5	Equivalence data (reliable/quantifiable)
6	Evaluation of state of the art, including evaluation of clinical data from similar devices
7	Complaints and vigilance data; curated data
8	Proactive PMS data, such as that derived from surveys
9	Individual case reports on the subject device
10	Compliance to non-clinical elements of common specifications considered relevant to device safety and performance
11	Simulated use/animal/cadaveric testing involving healthcare professionals or other end users
12	Pre-clinical and bench testing/compliance to standards

Considering [device short name] is a legacy/MDR class X device, exempted from clinical investigation as described in Section 3.2.1 only for class III/implantable devices, is/is not a well-established technology and the lack of novelty/or the novelty identified Section 2.3.1, [manufacturer short name] determined the minimum level of clinical evidence necessary to demonstrate the conformity to applicable GSPRs is:

• Rank X clinical evidence
• Rank Y clinical evidence
• Rank Z clinical evidence

Section 3.4.1 of the CER will confirm if the available clinical data achieve the sufficient level of clinical evidence to support the safety and performance of [device short name] for the medical condition(s) for which the device is intended to be used.

To support the decision, see the suggested recommendations (to be customized with the device):

Scenario	Device class	Estimated minimum level of clinical evidence required
1	Class I/IIa/IIb meeting requirements from Article 61 (10)	Rank 10-12 (non-clinical evidence)
Legacy devices or already commercialized MDR devices
2	Class I (Is, Im, Ir)*	Rank 10-12 (non-clinical evidence) + Rank 7 (complaints and vigilance)
3	Class IIa non-implantable	Rank 10-12 (non-clinical evidence) + Rank 7 (complaints and vigilance) + Planned Rank 8 (PMCF activities, e.g., patient/user survey)
4	Class IIb non-implantable	Rank 10-12 (non-clinical evidence) + Rank 7 (complaints and vigilance) + Rank 4 (data from subject device) or Rank 5 (data from equivalent device2) + Planned Rank 8 (PMCF activities, e.g., patient/user survey)
5	Implantable/Class III	Rank 10-12 (non-clinical evidence) + Rank 7 (complaints and vigilance) + Rank 4 (data from subject device) or Rank 5 (data from equivalent device1) + Planned Rank 4 or higher (PMCF activities, e.g., PMCF study/investigation)
6	Implantable/Class III and WET	Rank 10-12 (non-clinical evidence) + Rank 7 (complaints and vigilance) + Rank 6 (data from similar devices) + Rank 4 (data from subject device) or Rank 5 (data from equivalent device1) + Planned Rank 8 (PMCF activities, e.g., patient/user survey)
New MDR devices
7	Class I	Rank 10-12 (non-clinical evidence) + Rank 5 (data from equivalent device)
8	Class I (Is, Im, Ir) and Class IIa non-implantable	Rank 10-12 (non-clinical evidence) + Rank 5 (data from equivalent device) + Planned Rank 8 (PMCF activities, e.g., patient/user survey)
9	Class IIb non-implantable	Rank 10-12 (non-clinical evidence) + Rank 4 (clinical investigation), OR Rank 5 (data from equivalent device) + Planned Rank 8 (PMCF activities, e.g., patient/user survey), or Planned Rank 4 or higher (PMCF activities, e.g., PMCF study/investigation)
10	Implantable/Class III	Rank 10-12 (non-clinical evidence) + Rank 4 (clinical investigation), OR Rank 5 (data from equivalent device4) + Planned Rank 4 or higher (PMCF activities, e.g., PMCF study/investigation)

Summary and appraisal of clinical data for S&P

Summary and appraisal of pre-clinical study

[Device short Name] was designed, manufactured, packaged and labeled according to harmonized, European or technical standards recognized for the device intended use. The description of tests and results are summarized in the following table.

Table 38:Pre-clinical testing

Description of Test	Testing Method (standards, CS)	Results	Testing Report	Appraisal

[Device short Name] conforms with the technical SOTA recognized in Europe through compliance with the recognized standards and common specifications. The preclinical data are appraised Rank 10 and/or 11 and/or 12 according to MDCG 2020-6 as described in Appendix B – Appraisal criteria.

More information can be described on the test protocols and results in subsections. This is specifically relevant when Article 61(10) is used.

Summary and appraisal of clinical investigation

X clinical investigations have been performed to demonstrate the safety and performance of [Device short name] that comprise:

• XXX
• XXX

The appraisal criteria used for the assessment of clinical investigation are described in Appendix B – Appraisal criteria.

The following table further describes the clinical investigation(s) performed.

Table 39: Clinical investigation summary and appraisal

Reference	CI1
Identity of the investigation/study:
Geography area:	Indicate the country and if in EU (the applicable regulation when the study was conducted i.e., MDD/MDR).
Source:	Provide link in EUDAMED, if not available, the link in the clinical trial database or the reference to the literature article.
Identity of the device:	Including model(s) and version(s)
Intended use of the device:
Objectives:
Study design:	Randomized controlled trial, other pivotal trial, short-term feasibility study, other;					Follow-up:
Primary endpoint(s):
Secondary endpoint(s):
Inclusion criteria:						Exclusion criteria:
Summary of method:
Number of enrolled patients:	Including if applicable in different treatment arms
Study population:	Main baseline characteristics of each study group, including gender and age of enrolled subjects
Summary of results:
Performance endpoint(s)	Table to be customized as needed Endpoints Timepoints Results Performance endpoints Indicate results OR comparative results with p value
Safety endpoint(s)	Table to be customized as needed Endpoints Timepoints Results Safety endpoints Indicate results OR comparative results with p value
Adverse events and side-effects	Table to be customized as needed Events Number Rate Indicate rate in relation to time (e.g., PPY)
Status:	Complete Ongoing (% of completeness of FU) Complete but still ongoing for long-term FU
Limitations:	high loss to follow-up, or potential confounding factors that may question the results.
Deficiency:	Any device deficiency and any device replacements related to safety and/or performance during the study
Appraisal:	Rank:		LoE:		Suitability:			Contribution:

Reference	CI2
Identity of the investigation/study:
Geography area:	Indicate the country and if in EU (the applicable regulation when the study was conducted i.e., MDD/MDR).
Source:	Provide link in EUDAMED, if not available, the link in the clinical trial database or the reference to the literature article.
Identity of the device:	Including model(s) and version(s)
Intended use of the device:
Objectives:
Study design:	Randomized controlled trial, other pivotal trial, short-term feasibility study, other;					Follow-up:
Primary endpoint(s):
Secondary endpoint(s):
Inclusion criteria:						Exclusion criteria:
Summary of method:
Number of enrolled patients:	Including if applicable in different treatment arms
Study population:	Main baseline characteristics of each study group, including gender and age of enrolled subjects
Summary of results:
Performance endpoint(s)	Table to be customized as needed Endpoints Timepoints Results Performance endpoints Indicate results OR comparative results with p value
Safety endpoint(s)	Table to be customized as needed Endpoints Timepoints Results Safety endpoints Indicate results OR comparative results with p value
Adverse events and side-effects	Table to be customized as needed Events Number Rate Indicate rate in relation to time (e.g., PPY)
Status:	Complete Ongoing (% of completeness of FU) Complete but still ongoing for long-term FU
Limitations:	high loss to follow-up, or potential confounding factors that may question the results.
Deficiency:	Any device deficiency and any device replacements related to safety and/or performance during the study
Appraisal:	Rank:		LoE:		Suitability:			Contribution:

In conclusion, X clinical investigations have been conducted to support the safety and performance of [Device short name] when used as intended and are classified Rank 1 (X studies), Rank 2 (X studies), Rank 3 (X studies) per the MDCG 2020-6 (April 2020). A total of X patients has been treated/diagnosed with an age from X to X years old. stratify the data as required if sub-indications/sub-populations are claimed.

The results obtained for the key safety and performance criteria defined to support the safety, performance and benefits claims as well as the qualitative and quantitative information related to clinical risks have been summarized in the following tables.

Table 40: Overall summary of clinical investigations

Key Outcome Parameters	Timepoints	Outcomes

Table 41: Overall summary of risks during clinical investigations

Clinical risks	Rate
Device-related risks
Patient-related risks

Summary and appraisal of PMCF specific procedure

X PMCF investigations/studies have been performed to demonstrate the safety and performance of [Device short name] that comprise:

• XXX
• XXX

The appraisal criteria used for the assessment of PMCF activities are described in Appendix B – Appraisal criteria.

The following table further describes the PMCF investigations/studies performed.

Table 42: PMCF investigation summary and appraisal

Reference	PMCF1
Identity of the investigation/study:
Geography area:	Indicate the country and if in EU (the applicable regulation when the study was conducted i.e., MDD/MDR).
Source:	Provide link in EUDAMED, if not available, the link in the clinical trial database or the reference to the literature article.
Identity of the device:	Including model(s) and version(s)
Intended use of the device:
Objectives:
Study design:	Randomized controlled trial, other pivotal trial, short-term feasibility study, other;					Follow-up:
Primary endpoint(s):
Secondary endpoint(s):
Inclusion criteria:						Exclusion criteria:
Summary of method:
Number of enrolled patients:	Including if applicable in different treatment arms
Study population:	Main baseline characteristics of each study group, including gender and age of enrolled subjects
Summary of results:
Performance endpoint(s)	Table to be customized as needed Endpoints Timepoints Results Performance endpoints Indicate results OR comparative results with p value
Safety endpoint(s)	Table to be customized as needed Endpoints Timepoints Results Safety endpoints Indicate results OR comparative results with p value
Adverse events and side-effects	Table to be customized as needed Events Number Rate Indicate rate in relation to time (e.g., PPY)
Status:	Complete Ongoing (% of completeness of FU) Complete but still ongoing for long-term FU
Limitations:	high loss to follow-up, or potential confounding factors that may question the results.
Deficiency:	Any device deficiency and any device replacements related to safety and/or performance during the study
Appraisal:	Rank:		LoE:		Suitability:			Contribution:

Reference	PMCF2
Identity of the investigation/study:
Geography area:	Indicate the country and if in EU (the applicable regulation when the study was conducted i.e., MDD/MDR).
Source:	Provide link in EUDAMED, if not available, the link in the clinical trial database or the reference to the literature article.
Identity of the device:	Including model(s) and version(s)
Intended use of the device:
Objectives:
Study design:	Randomized controlled trial, other pivotal trial, short-term feasibility study, other;					Follow-up:
Primary endpoint(s):
Secondary endpoint(s):
Inclusion criteria:						Exclusion criteria:
Summary of method:
Number of enrolled patients:	Including if applicable in different treatment arms
Study population:	Main baseline characteristics of each study group, including gender and age of enrolled subjects
Summary of results:
Performance endpoint(s)	Table to be customized as needed Endpoints Timepoints Results Performance endpoints Indicate results OR comparative results with p value
Safety endpoint(s)	Table to be customized as needed Endpoints Timepoints Results Safety endpoints Indicate results OR comparative results with p value
Adverse events and side-effects	Table to be customized as needed Events Number Rate Indicate rate in relation to time (e.g., PPY)
Status:	Complete Ongoing (% of completeness of FU) Complete but still ongoing for long-term FU
Limitations:	high loss to follow-up, or potential confounding factors that may question the results.
Deficiency:	Any device deficiency and any device replacements related to safety and/or performance during the study
Appraisal:	Rank:		LoE:		Suitability:			Contribution:

X PMCF activities have been conducted to support the safety and performance of [Device short name] when used as intended and are classified Rank 1 (X studies), Rank 2 (X studies), Rank 3 (X studies), Rank 8 (X surveys) per the MDCG 2020-6 (April 2020). A total of X patients has been treated/diagnosed with an age from X to X years old. Stratify the data as required if sub-indications/sub-populations are claimed.

The results obtained for the key safety and performance criteria defined to support the safety, performance and benefits claims as well as the qualitative and quantitative information related to clinical risks have been summarized in the following tables.

Table 43: Overall summary of PMCF investigations/studies

Key Outcome Parameters	Timepoint	Outcomes

Table 44: Overall summary of risks during PMCF investigations/studies

Clinical risks	Rate
Device-related risks
Patient-related risks

Summary and appraisal of published clinical literature

The implementation of literature searches resulted in the inclusion of XX articles with the objective to establish the safety and performance profile of [device short name] (objective 1) as described in Appendix G – Literature search report for S&P.

The following figure describes the selection process used.

Figure 5: Literature search results for [device short name]

Total Number of results

n=

Number of results without duplicates

n=

Number of results after Level 1 screening:

n=

Number of results after Level 2 screening:

n=

Figure to be completed

The results of each article are summarized in the following sections ordered based on the articles quality evaluated using the appraisal criteria defined in Appendix B – Appraisal criteria.

High quality articles

X articles of high quality have been collected to demonstrate the safety and performance of [Device short Name]. The appraisal criteria used for the assessment of articles are described in Appendix B – Appraisal criteria.

The following table further describes the articles of high-quality.

/OR No articles of high quality found

Table 45: Summary and appraisal of high-quality literature articles

Reference
Title:
Appraisal criteria
Oxford Loe:	LOE X
Suitability	Device Application Patient Report
Contribution	Outcome Follow-up Statistics Clinical significance
Rank (MDCG 2020-6)	Rank 4/Rank 5
Appraisal conclusion	High quality/low quality/off label use
Article description:
Objective:
Study design:
Method:
FU:
Statistics:
Demographic data:	n=XX	Sex: X males/Y females
	mean age: (from X to Y years old) describe in more details when necessary and when stratified data are available	Medical indication: XXX Provide stratified data when necessary
Device used:	Include device name and characteristics when possible (e.g., size, model number, etc.)
Summary of results
Performance:	Endpoints Timepoints Results Performance endpoints Indicate results OR comparative results with p value
Safety:	Endpoints Timepoints Results Safety endpoints Indicate results OR comparative results with p value
Clinical risks:	Events Number Rate Indicate rate in relation to time (e.g., PPY)
Conclusion of the authors:

Reference
Title:
Appraisal criteria
Oxford Loe:	LOE X
Suitability	Device Application Patient Report
Contribution	Outcome Follow-up Statistics Clinical significance
Rank (MDCG 2020-6)	Rank 4/Rank 5
Appraisal conclusion	High quality/low quality/off label use
Article description:
Objective:
Study design:
Method:
FU:
Statistics:
Demographic data:	n=XX	Sex: X males/Y females
	mean age: (from X to Y years old) describe in more details when necessary and when stratified data are available	Medical indication: XXX Provide stratified data when necessary
Device used:	Include device name and characteristics when possible (e.g., size, model number, etc.)
Summary of results
Performance:	Endpoints Timepoints Results Performance endpoints Indicate results OR comparative results with p value
Safety:	Endpoints Timepoints Results Safety endpoints Indicate results OR comparative results with p value
Clinical risks:	Events Number Rate Indicate rate in relation to time (e.g., PPY)
Conclusion of the authors:

Low-quality articles

X articles of low quality have been collected to demonstrate the safety and performance of [Device Short Name]. The appraisal criteria used for the assessment of articles are described in Appendix B – Appraisal criteria.

The following table further describes the articles of low-quality.

/OR No articles of low quality found

Table 46: Summary and appraisal of low-quality literature article

Reference
Title:
Appraisal criteria
Oxford Loe:	LOE X
Suitability	Device Application Patient Report
Contribution	Outcome Follow-up Statistics Clinical significance
Rank (MDCG 2020-6)	Rank 4/Rank 5
Appraisal conclusion	High quality/low quality/off label use
Article description:
Objective:
Study design:
Method:
FU:
Statistics:
Demographic data:	n=XX	Sex: X males/Y females
	mean age: (from X to Y years old) describe in more details when necessary and when stratified data are available	Medical indication: XXX Provide stratified data when necessary
Device used:	Include device name and characteristics when possible (e.g., size, model number, etc.)
Summary of results
Performance:	Endpoints Timepoints Results Performance endpoints Indicate results OR comparative results with p value
Safety:	Endpoints Timepoints Results Safety endpoints Indicate results OR comparative results with p value
Clinical risks:	Events Number Rate Indicate rate in relation to time (e.g., PPY)
Conclusion of the authors:

Reference
Title:
Appraisal criteria
Oxford Loe:	LOE X
Suitability	Device Application Patient Report
Contribution	Outcome Follow-up Statistics Clinical significance
Rank (MDCG 2020-6)	Rank 4/Rank 5
Appraisal conclusion	High quality/low quality/off label use
Article description:
Objective:
Study design:
Method:
FU:
Statistics:
Demographic data:	n=XX	Sex: X males/Y females
	mean age: (from X to Y years old) describe in more details when necessary and when stratified data are available	Medical indication: XXX Provide stratified data when necessary
Device used:	Include device name and characteristics when possible (e.g., size, model number, etc.)
Summary of results
Performance:	Endpoints Timepoints Results Performance endpoints Indicate results OR comparative results with p value
Safety:	Endpoints Timepoints Results Safety endpoints Indicate results OR comparative results with p value
Clinical risks:	Events Number Rate Indicate rate in relation to time (e.g., PPY)
Conclusion of the authors:

Off-label use

X articles on off label use have been collected to demonstrate the safety of [Device Short Name]. The appraisal criteria used for the assessment of articles are described in Appendix B – Appraisal criteria.

The following table further describes the articles with off label use.

Table 47: Summary and appraisal of off-label literature articles

Reference
Title:
Appraisal criteria
Oxford Loe:	LOE X
Suitability	Device Application Patient Report
Contribution	Outcome Follow-up Statistics Clinical significance
Rank (MDCG 2020-6)	Rank 4/Rank 5
Appraisal conclusion	High quality/low quality/off label use
Article description:
Objective:
Study design:
Method:
FU:
Statistics:
Demographic data:	n=XX	Sex: X males/Y females
	mean age: (from X to Y years old) describe in more details when necessary and when stratified data are available	Medical indication: XXX Provide stratified data when necessary
Device used:	Include device name and characteristics when possible (e.g., size, model number, etc.)
Summary of results
Safety and Performance:	N/A – Results of device evaluation regarding safety and performance endpoints are not analyzed for off label use articles. Only clinical risks observed are reviewed.
Clinical risks:	Events Number Rate Indicate rate in relation to time (e.g., PPY)
Conclusion of the authors:

Reference
Title:
Appraisal criteria
Oxford Loe:	LOE X
Suitability	Device Application Patient Report
Contribution	Outcome Follow-up Statistics Clinical significance
Rank (MDCG 2020-6)	Rank 4/Rank 5
Appraisal conclusion	High quality/low quality/off label use
Article description:
Objective:
Method:
FU:
Statistics:
Demographic data:	n=XX	Sex: X males/Y females
	mean age: (from X to Y years old) describe in more details when necessary and when stratified data are available	Medical indication: XXX Provide stratified data when necessary
Device used:	Include device name and characteristics when possible (e.g., size, model number, etc.)
Summary of results
Safety and Performance:	N/A – Results of device evaluation regarding safety and performance endpoints are not analyzed for off label use articles. Only clinical risks observed are reviewed.
Clinical risks:	Events Number Rate Indicate rate in relation to time (e.g., PPY)
Conclusion of the authors:

Overall conclusion regarding literature articles

A total of X literature articles has been found to support the safety and performance of [Device short name] including X articles of high quality and X articles of low quality. In addition, X articles have been found for off-label uses.

X articles are Rank 4 on [Device short name] and X articles are Rank 5 on a device equivalent to [Device short name] per MDCG 2020-6 (April 2020).

A total of X patients has been treated/diagnosed with an age from X to X years old. Please stratify the data as required if sub-indications/sub-populations are claimed.

The results obtained for the key criteria defined to support the safety, performance and benefits claims as well as the qualitative and quantitative information related to clinical risks have been summarized in the following tables.

Table 48: Overall summary of literature articles

Key Outcome Parameters	Timepoint	Outcomes

Table 49: Overall summary of risks in literature articles

Clinical risks	Rate
Device-related risks
Patient-related risks

Summary and appraisal of external PMS database

Please remove the section if no PMS database is queried.

A search in vigilance and FSCA databases has been conducted to retrieve the clinical risks related to [Device Short Name]. For the period from DD-MM-YYYY to DD-MM-YYYY, a total of XX vigilance and XX FSCA have been retrieved in the external PMS database consulted for the [Device short name] or its equivalent device.

The protocol and report are respectively Appendix D – Clinical data search protocol and Appendix H – Vigilance/recall search report.

The results are appraised with a Rank 7 according to the criteria described in Appendix B – Appraisal criteria.

The following table presents the number of relevant events retrieved for all databases consulted.

Table 50: Results of vigilance/recall search implementation of subject device

Database	Objective	Vigilance/recall search report	Number of results:				Event type			FSCA
			Total	Excluded	Duplicate	Included	Device-related	Patient-related	Death
FDA MAUDE	3
	3
FDA Medical Device Recalls	3
	3
FDA TPLC	3
	3
ANSM safety information	3
	3
Bfarm Field Corrective Actions	3
	3
MHRA Alerts, recalls and safety information: drugs and medical devices	3
	3
SwissMedic – FSCA and recall	3
	3
DAEN (Database of Adverse Event Notifications) – medical devices	3
	3
SARA (System for Australian Recall Actions)	3
	3
Canadian recalls and safety alerts	3
	3
TOTAL		All

The vigilance and recall review identified clinical risks including undesirable side-effects related to [Device Short Name], or its equivalent device as reported in the following table.

Table 51: Risks from public vigilance/recall databases

Events Reported	Event types	Occurrence
		Subject device	Equivalent device
Device-related risks
Patient-related risks

Summary and appraisal of SSCP clinical data of equivalent devices

Only applicable to class III and implantable equivalent devices

For MDR class III and implantable devices, manufacturers are required to make publicly available the summary of safety and clinical performance (SSCP) via EUDAMED. Until EUDAMED becomes fully functional, SSCPs may be found on the websites of manufacturers or in other public locations.

A search has been implemented to find the SSCPs of MDR devices equivalent to [device short name] starting from EUDAMED and manufacturer websites.

The result of the search has been extracted to ensure the characterization of safety and performance of equivalent devices. The following SSCPs have been retrieved:

Table 52: Impact assessment of SSCP clinical data on equivalent devices

Equivalent device	Document number	Link to SSCP
XXXX
XXXX

The following table describes the study information, device and demographic characteristics for SSCP clinical data specific to equivalent devices for the purpose of establishing their safety and performance profile.

Table 53: Summary of published clinical SSCP clinical data on equivalent devices

Title of clinical data	SSCP clinical data type	Device characteristics		Indication	Number of patients	Demographic characteristics		Follow-up
		Device Name	Size			Age	Sex

All articles have been appraised per the requirements described in Appendix B – Appraisal criteria. The following table describes the results of appraisal process:

Table 54: Appraisal of SSCP clinical data on equivalent devices

Clinical data ref	MDCG 2020-6	Oxford LoE	Suitability				Contribution
			D	A	P	R	T	O	F	S	C
	Rank 6
	Rank 6

Safety outcome parameters related to equivalent devices

The safety outcome parameters and specifications as discussed in the SSCP clinical data on equivalent devices are described in the following table.

Table 55: Summary of safety outcome parameters on equivalent devices

Clinical data ref.	Safety outcome parameters	Results			Comments
		Device	Timepoint	Specification

Performance outcome parameters related to equivalent devices

The performance outcome parameters and specifications as discussed in the SSCP clinical data on equivalent devices are described in the following table.

Table 56: Summary of performance outcome parameters on equivalent devices

Article ref.	Performance outcome parameters	Results			Comments
		Device	Timepoint	Specification

Clinical risks reported with equivalent devices

The following table describes the clinical risks identified in the SSCP clinical data collected on equivalent devices.

Table 57: Summary of clinical risks on equivalent devices

Article ref.	Clinical risks	Results			Comments
		Device	Timepoint	Rate

Summary and appraisal of internal PMS data

The PMS data resulting from the PSUR/PMS report (see Section 1.11) and especially, the sales, complaints and vigilance, are summarized to emphasize the device and patient-related risks for the [Device short name].

The following findings have been identified in the PSUR/PMS report (see Section 1.11):

• XXX Identify the conclusion of the PSUR/PMS report for corrective action,
• XXX Identify the conclusion of the PSUR/PMS report regarding the need to update the CER,
• XXX Identify the conclusion of the PSUR/PMS report regarding trend analysis,
• XXX Identify the conclusion of the PSUR/PMS report regarding the reporting to authorities

The PMS data are appraised Rank 7 per the criteria described in Appendix B – Appraisal criteria.

The following tables present an overview of the available PMS data for the period from XX/XX/XXXX to XX/XX/XXXX.

Table 58: Complaints and vigilance per year

Year	World-Wide					Europe
	Sales	Complaints		Vigilance		Sales	Complaints		Vigilance
		n	rate	n	rate		n	rate	n	rate

Table 59: Complaints and vigilance per model if several Basic UDI-DI/models involved

Model	World-Wide					Europe
	Sales	Complaints		Vigilance		Sales	Complaints		Vigilance
		n	rate	n	rate		n	rate	n	rate

Table 60: Type of device problem

Device problem	Region	YYYY	YYYY	YYYY	YYYY
Reported incidents
	EU
	WW
	EE
	WW
Non-serious incident – Known undesirable side-effects
	EU
	WW
	EU
	WW

Table 61: Type of patient problem

Type of patient problem	Region	YYYY	YYYY	YYYY	YYYY
Reported incidents
	EU
	WW
	EU
	WW
Non-serious incident – Known undesirable side-effects
	EU
	WW
	EU
	WW

Table 62: Type of patient problem

Type of root-cause	Region	YYYY	YYYY	YYYY	YYYY
Reported incidents
	EU
	WW
	EU
	WW
Non-serious incident – Known undesirable side-effects
	EU
	WW
	EU
	WW

[Manufacturer short name] has also conducted X CAPA related to the device as indicated in the following table.

Table 63: Summary of CAPA

Type of action	Initiation date	Scope of the CAPA	Status of the CAPA	Manufacturer Reference Number	CAPA description	Root cause	Effectiveness of the CAPA if closed
CA	XX/MM/YYYY		[in process, finalized]			DXXXX [code] WWWW [terms]	[Effectiveness verified, CAPA in progress]
PA

[Manufacturer short name] has also conducted X Field Safety Corrective Action (FSCA) as indicated in the following table.

Table 64: Summary of Field Safety Corrective actions

Type of action	Issuing date	Scope of the FSCA	Status of the FSCA	Manufacturer Reference Number	Rationale and description of action taken	Impacted Regions
[Recall, FSN,…]	XX/MM/YYYY		[in process, finalized]

Conclusion of available clinical data and appraisal

The different sources of clinical data have been consulted and resulted in the identification of clinical data applicable to [Device short name] and its equivalent device, to support the device safety and performance.

All available clinical data supporting the compliance of device under evaluation to applicable GSPRs have been appraised as summarized in the following table.

Table 65: Appraisal summary of clinical data

Reference	Clinical data	Appraisal
		Contribution	Suitability	LoE	Rank
Clinical investigation(s)
CI1
CI2
PMCF activities
PMCF1
PMCF2
Literature
Vigilance and recall in publicly available database
–	Data presented in Section 3.3.4	N/A	N/A	N/A	7
PMS data generated and held by the manufacturer
–	Data presented in Section 3.3.5	N/A	N/A	N/A	7
Preclinical data
–	Preclinical Data presented in Section 3.3.1	N/A	N/A	N/A

The data summarized and appraised in Section 3.3 are analysed in Section 3.4 to justify the sufficient level of available clinical data to support the compliance to the applicable GSPRs.

Clinical data analysis

Level of clinical evidence available

The level of clinical data required has been determined in Section 3.2. As described in the following table, the minimum level of clinical data required to support the compliance to relevant GSPRs is achieved for all critical device characteristics and all critical characteristics of the intended use.

The device/intended use characteristics in the table below shall include all critical characteristics identified in Section 1.5; (e.g., the intended use shall include all sub-indications in which the device is claimed to be used).

Table 66: Level of available clinical data

Intended use Device Characteristics		Indication 1	Indication 2	Indication 3
Design		Rank 12 (Section X) Rank 7 (Section X): XXX devices sold and 0.0001% of complaints 0% reported to CA Rank 3 (Section X): Y CI, Y articles with n=XXX from Z to Z
Type
Version
Size

For all weaknesses/gaps identified, describe the PMCF activities planned/ongoing to cover the problem.

Safety evaluation (GSPR 1, 2, 3)

[Device short name] shall be designed and manufactured in way that does not compromise the clinical condition and the safety of patients and intended users. The clinical evaluation has identified the possible risks during normal conditions of use with the purpose to confirm the suitability of risk estimation and the risks are mitigated as far as possible using the principles described in EN ISO 14971:2019+A11:2021. In addition, the review of resulting residual risks will confirm the suitability of labeling. The following table summarizes the results of this review for all risks identified during the clinical evaluation.

Table 67: Adequacy of clinical data with IFU and risk management file

Clinical risks (including side-effects)	Risk Management File	Instruction for use
	Document of reference: See section 1.11	Document of reference: see section 1.11
From SOTA (including similar devices) Remove for devices with a long history of use
	“XXX” Refer to the risk and risk estimation The risk has been mitigated AFAP as indicated	“Xxxxxxxx” Refer to the IFU statement covering the risk
From Equivalent device Remove if not applicable
From Device under evaluation

As described in Section 3.3.5, no trends have been identified exceeding the threshold values defined in the risk analysis for the non-significant incidents or known undesirable side-effects. Alternatively, describe the trends exceeding the threshold value, the associated CAPA and the conclusion on the B/R profile.

All serious risks^[1] identified during the clinical use of the device are evaluated for acceptability against the acceptance criteria defined based on the current knowledge and SOTA (including similar devices). The acceptability of risks is described in Section 3.4.3.

All risks identified though the clinical evaluation have been evaluated and mitigated as far as possible and are compatible with a high level of protection of health and safety. The labeling has also been reviewed and is aligned with the risks identified during the clinical evaluation.

Acceptability of clinical risks and side-effects (GSPR 1, 8)

A systematic search of clinical data (See Section 3.3) for the period from DD/MM/YYYY to DD/MM/YYYY raised a list of clinical risks for the use of [Device short name] or equivalent device. The following table gathers the clinical risks identified for the use of the subject or equivalent device with the corresponding rates, when available.

A systematic search of clinical data on similar devices (see Section 2.2) for the period from DD/MM/YYYY to DD/MM/YYYY allowed the identification of acceptance criteria for the recognized clinical risks established in the SOTA.

The following table compares the quantitative data resulting from the use of [Device short name] or equivalent device to the acceptance criteria defined based on the SOTA.

Table 68: Acceptability of clinical risks

Clinical risks on [Device short name]	State of the Art rates	Reported rates for [device short name]	Acceptability and rationale
	From X to X	Clinical investigation: From X to X	Yes/No
		Clinical literature: From X to X

A tabular format is recommended but all clinical risks can be presented in sub-sections;

When clinical risks do not meet the acceptance criteria, a justification shall be indicated based on (for instance):

• Isolated case
• Significance of the risks
• Other recognized risks that are not reported for the subject device
• Discrepancy of results
• Benefits of the device
• Other

PMCF may be required for the risks that do not meet the acceptance criteria with a non-sufficiently strong rationale. Though the benefits of using the device may outweigh those risks, specific monitoring shall be implemented.

In conclusion, all clinical risks identified for the use of [Device short name] or the equivalent device, including all known undesirable side-effects have been evaluated meeting the acceptance criteria taking into account the current knowledge and SOTA.

Performance evaluation (GSPR 1, 6)

Based on the pre-clinical data presented in Section 3.3.1, [Manufacturer short name] demonstrated [Device short name] has been designed, manufactured, labelled and packaged according to the current SOTA, meeting the applicable requirements of European harmonized, international or technical standards and Common Specifications (CS) recognized in Europe for the generic device type.

The performance of the [Device short name] has been evaluated through the review of cumulative evidence for the outcome parameters (i.e., endpoints) that support the performance and safety claims as compared to the acceptance criteria defined based on the SOTA (See Section 2.2.1.3).

The acceptance criteria for the key safety and performance outcome parameters were within the acceptance criteria, except for the following for which the gap has been evaluated clinically non-significant:

• XXX (justify the gaps)

In addition, [Manufacturer short name] considered the minimum level of clinical data required as determined in Section 3.2 has been achieved for all the clinical claims available in the labelling or marketing materials for the indication and population treated/diagnosed with the device.

The following table summarizes the available clinical data for the safety and performance allegations claimed by [Manufacturer short name].

Table 69: Substantiation of S&P claims

Claims	Type of claims	Outcome parameters	Results		Acceptable
			Clinical data	Rank
Performance
	Clinical/non-clinical		Clinical investigation: include the result (if comparative data required, include the p value), include the number of patients and source
			PMCF: include the result (if comparative data required, include the p value), include the number of patients and source
			Literature: include the result (if comparative data required, include the p value), include the number of patients and source
Safety

Note: the general S&P claims shall be substantiated for the complete indication or for all types of targeted patients; an additional column may be integrated for that purpose if necessary.

Benefit/risk profile (GSPR 8)

The description of B/R profile should be sufficient on its own. Information from other sections can be repeated here.

[Device short name] is a class X device according to Annex VIII of the MDR.

[Device short name] is XXX include a short device description.

[Device short name] is indicated for XXX indicate the exact indication for use statement.

A systematic search of clinical data has been conducted and relevant safety and performance data on [Device short name] and equivalent device, have been found:

• X clinical investigations on the subject device or equivalent device (see Section 3.3.1)
• X literature articles on the subject device or equivalent device (see Section 3.3.3)
• X PMCF specific procedures on the subject device or equivalent device, under the form of [Registry, PMCF investigation, PMCF user survey, etc;] (see Section 3.3.2)
• PMS data generated and held by [manufacturer short name] (see Section 3.3.5) and PMS data from external publicly available database (see Section 3.3.4).

As discussed in Section 3.4.1 and using the criteria defined in Appendix III of the MDCG 2020-6, [Manufacturer short name] evaluated a sufficient level of clinical evidence has been reached to demonstrate the safety and performance of [Device short name] for its intended use and support the compliance to relevant GSPRs. Highlight the need of PMCF if the level of clinical data is not reached for a specific indication/population/device in the range.

Safety

XXX number of devices sold/uses [Device short name] have been sold/used from DD/MM/YYYY to DD/MM/YYYY. For the same period, the corresponding PMS data generated and held [manufacturer short name] for [Device short name] showed an overall complaint rate of XX% and YY% of incidents reported to the regulatory authorities. Please customize if the CER includes different type of devices (e.g., implants and accessories) as the PMS data must be presented per type of products.

The trend analysis conducted according to Article 88 of the MDR did not show any significant increase in trends, and any increase in likelihood or severity of risks as compared to the threshold values defined in the risk management documents. Please identify any increased trend and how the trend has been justified and if necessary, the CAPA defined, impact on B/R profile and if they have been reported to the authorities.

Section 3.4.2 justified that all risks identified in the clinical data for [Device short name] and its equivalent device have been assessed, evaluated and mitigated as far as possible according to the principles described in EN ISO 14971:2019+A11:2021. In addition, Section 3.4.3 demonstrated that all clinical risks identified in the clinical data for [Device short name], including all known undesirable side-effects, have been accepted when weighted against the acceptance criteria determined based on the SOTA. A thorough review has been performed and documented in Section 3.4.2 confirming the Instructions for use are adequate and consistent with the clinical data and risk management documents.

Highlight any specific concerns related to clinical risks with the appropriate justification. Highlight the need of PMCF if required.

[manufacturer short name] also defined safety claims that have been substantiated by a sufficient level of clinical data as described in Section 3.4.4.

Performance

Based on the pre-clinical data presented in Section 3.3.1, [manufacturer short name] demonstrated [Device short name] has been designed, manufactured, labelled and packaged according to the current SOTA, meeting the applicable requirements of European harmonized, international or technical standards and Common Specifications (CS) recognized in Europe for the generic device type.

Section 3.4.4 also demonstrated that all performances claimed by [manufacturer short name] met the acceptance criteria defined based on the SOTA and have been substantiated by a sufficient level of clinical data.

Highlight any specific concerns related to clinical performance with the appropriate justification. Highlight the need of PMCF if required.

Those claims also led to clinical benefits for patients as delineated in the following table. The benefits for the use of [Device short name] are acceptable regarding the acceptance criteria defined based on the SOTA.

Table 70: Substantiation of clinical benefits

Clinical Benefits	Type of claims	Outcome parameters and specifications	Results		Acceptable
			Clinical data	Rank
	Clinical/Non-Clinical		Clinical investigation: include the result (if comparative data required, include the p value), include the number of patients and source
			PMCF: include the result (if comparative data required, include the p value), include the number of patients and source
			Literature: include the result (if comparative data required, include the p value), include the number of patients and source

Note: when necessary, a supplemental column shall be added to provide the evidence of benefits per indication or target population. Alternatively, the table can be duplicated.

Major clinical data (optional)

XXXX Overview and results of CI, pivotal articles on device under evaluation that support the benefits

Comparative data in the literature (optional)

XXXX Present all controlled/comparative data to highlight specific clinical data on device under evaluation in comparison to other alternatives/devices (to show the equivalence or superiority). This section can be removed if no comparative data are available.

Discussion of B/R concerns

There are no concerns or remaining questions regarding the available clinical data that support the compliance of [Device short name] with the applicable GSPRs.

/OR

XXXX When S&P concerns are raised in the CER without sufficient justification, that section should weigh how these concerns do not affect the B/R ratio in comparison to the SOTA. PMCF is generally recommended for confirmation.

Conclusion

The available clinical data confirm that the risks are acceptable when weighed against the intended benefits and are compatible with a high level of health and safety protection, taking into account current knowledge and the SOTA.

Conclusion

In respect of the requirements in 2017/745 (MDR), the clinical evidence support the safety and effectiveness of the [Device Short Name], and especially:

1. The benefit/risk ratio is acceptable taking into account current knowledge and the SOTA of the medical condition treated by [Device Short Name]
2. Undesirable side-effects and clinical risks are acceptable taking into account current knowledge and the SOTA of therapeutic alternatives
3. The information materials supplied by the [Manufacturer Short Name] as well as the intended purpose and risk reduction measures are adequate.
4. The claims foreseen by [Manufacturer Short Name] are adequate.
5. The clinical data, the information materials supplied by the manufacturer, and the risk management documentation for the device under evaluation are consistent with each other and aligned with current knowledge and the SOTA.
6. The device under evaluation, including the IFU, is suitable to the intended users, taking into account the usability of the device.
7. The PMS/PMCF plan in regard to the device under evaluation is appropriate.

The available clinical data confirm that the risks are acceptable when weighed against the intended benefits and are compatible with a high level of health and safety protection, taking into account current knowledge and the SOTA. In conclusion, the clinical data support the conformity of [device short name] with GSPR 1, X, X, X and 8.

However, in addition to the PMS activities (including PMCF general procedures), a PMCF specific procedure has been planned for the following objectives:

• XXX describe the objective as defined in Annex XIV Part B and a justification of the gaps/weaknesses identified (e.g., CER based on the equivalence, no data until the entire lifetime)

The following residual risks also need to be addressed through a specific PMCF procedure/or monitored during the PMS:

• XXX describe the objective as defined in Annex XIV Part B and a justification of the gaps/weaknesses identified (e.g., confirm the device safety)

/OR XXX include a rationale if no PMCF specific procedures is required

In conclusion, [Manufacturer Short Name] considers that GSPR 1, X, X, X and 8 of the MDR are met for the [Device Short Name] based on the available clinical evidence.

The CER will be issued every XX years, in alignment with the issuance of PSUR/PMS report and PMCF Evaluation Report Use same frequency as PMS/PMCF, or earlier if new data identified through PMS activities necessitate an update.

References

1. Author, Author. Title. Journal. REF (e.g., Month DD YYYY; N°:page-page). doi:
2. Author, Author. Title. Journal. REF (e.g., Month DD YYYY; N°:page-page). doi:

Full articles are included in Appendix J – Articles

Appendix A – Evaluator qualifications and declaration of interest

Copy/insert CV and declaration of interest

Appendix B – Appraisal criteria

Use Lex form: LEX-FORM-EU-010

Appendix C – Clinical/PMCF investigation protocols and reports

The following clinical/PMCF investigation protocols and reports have been issued with [device short name]

Table 71: CI/PMCF protocols and report for [Device short name]

Reference	Title	Protocol	Report

Appendix D – Clinical data search protocol

The following table is the history of clinical data search protocol implemented for [Device short name].

Table 72: Clinical data search protocol for [Device short name]

Reference	Objective	Period covered
XXXXX-PRO rev.1	1 – SOTA	From DD/MM/YYYY to DD/MM/YYYY
	2 – S&P AC	From DD/MM/YYYY to DD/MM/YYYY
	3 – S&P	From DD/MM/YYYY to DD/MM/YYYY

Use Lex form: LEX-FORM-EU-004

Appendix E – Literature search report for SOTA

The following table is the correspondence between clinical data search protocol and literature search reports implemented for SOTA.

Table 73: Literature search report for SOTA

Clinical Data Search Protocol	Literature Search Report
Reference	Objective	Reference	Period covered
XXXXX-PRO rev.1	1 – SOTA	XXXXX-RE-001 rev.1	From DD/MM/YYYY to DD/MM/YYYY
		XXXXX-RE-002 rev.1	From DD/MM/YYYY to DD/MM/YYYY
		XXXXX-RE-003 rev.1	From DD/MM/YYYY to DD/MM/YYYY

Use Lex form: LEX-FORM-EU-006

Appendix F – Literature search report for acceptance criteria (AC) of S&P

The following table is the correspondence between clinical data search protocol and literature search reports implemented for the definition of acceptance criteria of S&P.

Table 74: Literature search report for acceptance criteria (AC) of S&P

Clinical Data Search Protocol	Literature Search Report
Reference	Objective	Reference	Period covered
XXXXX-PRO rev.1	2 – S&P AC	XXXXX-RE-001 rev.1	From DD/MM/YYYY to DD/MM/YYYY
		XXXXX-RE-002 rev.1	From DD/MM/YYYY to DD/MM/YYYY
		XXXXX-RE-003 rev.1	From DD/MM/YYYY to DD/MM/YYYY

Use Lex form: LEX-FORM-EU-007

Appendix G – Literature search report for S&P

The following table is the correspondence between clinical data search protocol and literature search reports implemented for the S&P of [device short name].

Table 75: Literature search report for S&P

Clinical Data Search Protocol	Literature Search Report
Reference	Objective	Reference	Period covered
XXXXX-PRO rev.1	3 – S&P	XXXXX-RE-001 rev.1	From DD/MM/YYYY to DD/MM/YYYY
		XXXXX-RE-002 rev.1	From DD/MM/YYYY to DD/MM/YYYY
		XXXXX-RE-003 rev.1	From DD/MM/YYYY to DD/MM/YYYY

Use Lex form: LEX-FORM-EU-005

Appendix H – Vigilance/recall search report

The following table is the correspondence between clinical data search protocol and vigilance/recall search reports.

Table 76: Vigilance/recall search reports

Clinical Data Search Protocol	Vigilance/Recall Search Report
Reference	Objective	Reference	Period covered
XXXXX-PRO rev.1	1 – S&P AC 3 – S&P	XXXXX-RE-001 rev.1	From DD/MM/YYYY to DD/MM/YYYY
		XXXXX-RE-002 rev.1	From DD/MM/YYYY to DD/MM/YYYY
		XXXXX-RE-003 rev.1	From DD/MM/YYYY to DD/MM/YYYY

Use Lex form: LEX-FORM-EU-008

Appendix I – Existing literature and gap search report

The following table is the correspondence between clinical data search protocol, existing literature search report(s) and new literature search report(s).

Table 77: Existing and gap search reports

Clinical Data Search Protocol	Existing Literature Search considered		New Literature search reports and gap searches
Reference	Reference	Period covered	Reference	Period covered
XXXXX-PRO rev.1	XXX		XXXXX-RE-001 rev.1
	XXX
	XXX		XXXXX-RE-002 rev.1
	XXX

Use Lex form: LEX-FORM-EU-009

Appendix J – Articles

1. Serious shall be understood as risks meeting the reporting criteria in EU. All non-reportable risks being monitored via trend analysis. ↑