00 Front matter, introduction, scope, approach

Source: MDCG-2020-01.pdf pages 1-5 (document: MDCG 2020-13, Clinical evaluation assessment report template, July 2020)

Cover

MDCG 2020-13

Clinical evaluation assessment report template

July 2020

This document has been endorsed by the Medical Device Coordination Group (MDCG) established by Article 103 of Regulation (EU) 2017/745. The MDCG is composed of representatives of all Member States and a representative of the European Commission chairs it. The document is not a European Commission document and it cannot be regarded as reflecting the official position of the European Commission. Any views expressed in this document are not legally binding and only the Court of Justice of the European Union can give binding interpretations of Union law.

Contents

1. Introduction — p. 3
2. Scope — p. 3
3. Approach to Template — p. 4
4. Template CEAR — p. 6
   1. Section A: Administrative particulars (notified body, manufacturer, product and clinical evaluation report reference) — p. 6
   2. Section B: Reviewers involved in the notified body assessment of the clinical evaluation — p. 7
   3. Section C: Device description, classification, clinical evaluation plan, information materials supplied by the manufacturer, common specifications and harmonised standards applied, equivalence and state of the art — p. 8
   4. Section D: Clinical literature review — p. 15
   5. Section E: Clinical investigations and related documentation — p. 18
   6. Section F: PMS, PMCF and the plan for updates — p. 20
   7. Section G: IFU, SSCP, labelling and other information supplied with the device — p. 21
   8. Overall Conclusions: — p. 24
5. Specific Considerations — p. 25
   1. Section I: Clinical evaluation consultation procedure for certain class III and class IIb devices (Article 54) — p. 25
   2. Section J: Where demonstration of conformity based on clinical data is not deemed appropriate (Article 61(10)) — p. 28
   3. Section K: The voluntary clinical consultation on the clinical development strategy (Article 61(2)) — p. 30

List of acronyms

Acronym	Definition
CEAR	Clinical Evaluation Assessment Report
CECP	Clinical Evaluation Consultation Procedure
CER	Clinical Evaluation Report
CIP	Clinical Investigation Plan
EUDAMED	European Databank on Medical Devices
IFU	Instructions for Use
MDR	Medical Device Regulation (Regulation (EU) 2017/745 on medical devices)
PMCF	Post-Market Clinical Follow-up
PMS	Post-Market Surveillance
PSUR	Post-Market Surveillance Update Report
SRN	Single Registration Number
SSCP	Summary of Safety and Clinical Performance
TDAR	Technical Documentation Assessment Report
UDI-DI	Unique Device Identification Device Identifier

Introduction

A clinical evaluation assessment report (CEAR) is a report used by the notified body to clearly document the conclusions of its assessment of the clinical evidence presented by the manufacturer in the clinical evaluation report (CER) and the related clinical evaluation that was conducted — a core requirement of the Medical Device Regulation (EU) 2017/745 (MDR).

The clinical evaluation must be a part of the manufacturer's quality management. It should also be aligned with and reflected in other parts of the technical documentation, such as:

• The interface of the clinical evaluation with the risk management process and its appraisal and analysis of the pre-clinical and clinical evaluation and their relevance for the demonstration of conformity with the relevant requirements in Annex I.¹
• Post-market surveillance including any corrective and preventive actions involving the device.
• Post-market clinical follow-up plan and where appropriate the post-market clinical follow-up report.
• Instructions for use, which provide adequate information on intended purpose, proper use and warnings about risks to patients and healthcare practitioners.

As part of its conformity assessment activities the notified body shall examine, validate and verify that manufacturers' procedures and documentation adequately address the requirements relating to the technical documentation² and clearly document its assessment³.

The notified body shall review the clinical evidence presented by the manufacturer in the clinical evaluation report and the related clinical evaluation that was conducted, which includes⁴:

• Assessing the suitability of using data from claimed equivalent devices, taking into account factors such as new indications and innovation. The notified body shall clearly document its conclusions on the claimed equivalence, and on the relevance and adequacy of the data for demonstrating conformity. For any characteristic of the device claimed as innovative by the manufacturer or for new indications, the notified body shall assess to what extent specific claims are supported by specific pre-clinical and clinical data and risk analysis.
• Verifying that the clinical evidence and the clinical evaluation are adequate and shall verify the conclusions drawn by the manufacturer on the conformity with the relevant general safety and performance requirements. That verification shall include consideration of the adequacy of the benefit-risk determination, the risk management, the instructions for use, the user training and the manufacturer's post-market surveillance plan, and include a review of the need for, and the adequacy of, the PMCF plan proposed, where applicable.
• Considering the clinical evaluation and the benefit-risk determination, and whether specific milestones need to be defined to allow the notified body to review updates to the clinical evidence that result from post-market surveillance and PMCF data.

The outcome of this assessment must be clearly documented in the CEAR.⁵ A harmonised CEAR template provides a standardised method for documenting the notified body's assessment of the manufacturer's clinical evaluation and related documents. CEARs in this format will also support specific additional requirements such as the clinical evaluation consultation procedure⁶ and reviews by designating authorities.⁷

Scope

This template applies to MDR Annexes IX section 4 and Annex X section 3. It also applies to assessments of technical documentations on a sampling basis for class IIa/IIb devices in accordance with Annex IX sections 2.3 and 3.5 and

Section 10 of Annex XI(A).⁸ Aspects related to the clinical evaluation assessment are also laid down in Section 4.5.5 and other relevant sections of Annex VII. It also applies to medical devices for which clinical data is not deemed appropriate,⁹ to demonstrate conformity with Annex I, and the demonstration of an adequate justification for this.¹⁰

Approach to Template

Please note that the explanatory text under each heading provides brief descriptions of the type of information which will be included by the notified body, however it is not an all-inclusive list and further detail may be required depending upon the device or the intended purpose for which it will be used. This template represents the minimum content for a CEAR and needs to be incorporated into the process and procedures of the notified body.¹¹ The CEAR shall also make a recommendation to support a final review and a final decision to be taken by the notified body.

Any non-compliances identified during the assessment of the aspects described in the relevant sections of the template, as well as the appropriate follow up actions taken by the manufacturer to close them need to be documented. This template may be used by the notified body to document the non-compliance/deficiencies and queries raised during the assessment and the assessment of responses received. It is important to note that the completed CEAR may not necessarily contain comprehensive information regarding the non-compliance/deficiencies, which were raised by the notified body during the course of the assessment. The CEAR shall document the outcome¹² and the conclusions¹³ of the assessment.

Designating authorities shall assess whether the clinical evaluation assessment was conducted appropriately, considering the assessment, procedures, associated documentation and the conclusions;¹⁴ Designating authorities will have access to the complete 'audit trail' of the notified body.

Expert panels who are conducting a clinical evaluation consultation procedure shall assess the CEAR, however they may not have access to the complete conformity assessment for the device and associated procedures and documentation. To enable the expert panel work, the CEAR shall provide sufficient information with respect to the clinical evidence provided by the manufacturer, in particular concerning the benefit-risk determination, the consistency of that evidence with the intended purpose, including the medical indication or indications and the PMCF plan.¹⁵ Expert panels may also request the notified body to present its conclusions regarding the clinical evaluation assessment report.¹⁶

It is only once all the non-compliances have been closed out that the relevant tick-box should be completed to signal that the assessment is positive. In the rare event that there is one or more open minor non-compliances at the conclusion of the assessment stage, this must be clearly described in the template, together with appropriate follow-up actions to close them, and expected completion timelines to be followed by the manufacturer under the supervision of the notified body.

The sections covered in Annex I of this template are generally applicable depending on the type of assessment. The sections covered in Annex II may be applicable, depending upon the device under evaluation. All applicable sections should be completed, relevant conclusions reached and corresponding boxes ticked for the report to be complete. The CEAR should be signed-off by the relevant personnel in accordance with the quality management system of the notified body. When making available the CEAR to third parties, the notified body should treat the personal data within

Footnotes

1. MDR, Annex VII Section 4.5.1 and 4.5.5 ↩

2. MDR, Annexes II and III ↩

3. MDR Annex VII Section 4.5.5 and 4.6 ↩

4. MDR, Annex IX Sections 4.4 to 4.7 ↩

5. MDR, Annex IX 4.8 ↩

6. MDR, Article 54 ↩

7. MDR, Article 45 ↩

8. MDCG 2019-13 ↩

9. Article 61(10) ↩

10. Based on the results of the manufacturer's risk management and on consideration of the specifics of the interaction between the device and the human body, the clinical performance intended and the claims of the manufacturer. ↩

11. MDR, Annex VII Section 4.6 ↩

12. MDR, Annex IX Section 4.8 ↩

13. MDR, Annex VII Section 4.6 ↩

14. MDR, Article 45(3) ↩

15. MDR, Annex IX Section 5.1(c) ↩

16. MDR, Annex IX Section 5.1(b) ↩