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MDR-compliant Clinical Evaluation Report checklist

The Clinical Evaluation Report (CER) is developed based on the Clinical Evaluation Plan (CEP). While the CER partly reflects the content of the CEP, both documents serve distinct yet complementary roles. The CEP outlines the strategy and methodology for evaluating clinical data, while the CER documents the results and conclusions of this evaluation. Both are critical and mandatory under the EU MDR.

MDR-compliant Clinical Evaluation Report checklist

The Clinical Evaluation Report (CER) is developed based on the Clinical Evaluation Plan (CEP). While the CER partly reflects the content of the CEP, both documents serve distinct yet complementary roles. The CEP outlines the strategy and methodology for evaluating clinical data, while the CER documents the results and conclusions of this evaluation. Both are critical and mandatory under the EU MDR.

The Clinical Evaluation Report is crucial as it provides documented evidence of a medical device's safety, performance, and clinical benefits, ensuring compliance with EU MDR requirements.

The CER is so critical that Notified Bodies often assign specialized auditors to review it thoroughly, reflecting its central role in ensuring compliance with EU MDR requirements.



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Clinical Evaluation Plan checklist

Date:



1 Summary
2 Introduction
3 Terminology and device definition
4 Identification of the manufacturer
5 Identification of the subject device
5.1 Intended use
5.2 Classification
5.3 Device’s marketing history
5.4 Technical description, product design and characteristics
5.4.1 Identification of applied standards
5.4.2 Applied tests and quality criteria
6 Identification of target groups, indications, contraindications and clinical application
6.1 Intended patient target groups
6.2 User profile
6.3 Indications
6.4 Contraindications / limitations
6.5 Clinical application
6.6 Warnings and precautions
6.7 Clinical performance and degree of innovation
7 Risk analysis and risk management
7.1 General
7.2 Risk analysis and management file
8 Identification of relevant GSPRs
9 Alternative treatments and equivalent devices
9.1 Identification of alternative devices
9.1.1 Search methodology
9.2 Alternative devices
9.3 Identification of equivalent competitor products
9.3.1 Search methodology
9.3.2 Evidence for equivalence of the devices
9.4 Equivalent products
10 Clinical data
10.1 Sources of clinical data
10.1.1 Pre-market sources of clinical data
10.1.2 Post-market sources of clinical data
10.2 Clinical investigations
10.3 Evaluation of clinical performance and risks in the context of medical literature
10.3.1 Methodology of literature search
10.3.2 Search and selection results
10.4 Identification, analysis and appraisal of relevant available clinical data
10.5 Appropriate level of clinical evidence in view of the characteristics of the device and its intended purpose
10.6 Examination of qualitative and quantitative aspects of clinical safety and performance
10.7 Medical literature review
10.7.1 Clinical benefits of subject device and equivalents
10.7.2 Risks and limitations associated with subject device and equivalentsd>
10.8 Risks and limitations associated with device componenets
10.8.1 State of the art in context of medical literature review
10.9 Evaluation of clinical performance and risks in the context of market surveillance
10.9.1 Market surveillance by manufacturer
10.9.1.1 Number of devices sold
10.9.1.2 Summary of nonconformities, recalls, and incidents
10.9.1.3 Customer feedback
10.9.2 Market surveillance by authorities
11 Benefit-risk analysis
11.1 Evaluation of the description of the intended purpose of the device
11.2 Evaluation of the device’s benefits to the patient
11.3 Evaluation of the device's benefits compared with the alternative devices
11.4 Quantification of benefits to the patients
11.5 Evaluation of the clinical risks of the device
11.6 Evaluation of clinical risks of the device compared with the alternative devices
11.7 Benefit-risk issues relating to specific components
11.8 Evaluation of information supplied with the device
11.9 Acceptability of the benefit-risk ratio for the indications and intended purpose of the device
12 Clinical follow-up
13 Conclusion
14 Appendices
14.1 Appendix 1: list of documents reviewed for the purpose of this clinical evaluation
14.2 Appendix 2: CV of the author
14.3 Appendix 3: List of references

Literature search and appraisal report

Clinical evaluation involves conducting a scientific literature search and appraisal to gather and analyze relevant clinical data. This process ensures that the safety and performance of a medical device are supported by evidence. The findings from this evaluation must be documented, either directly within the Clinical Evaluation Report or in a separate, detailed document, to comply with regulatory requirements.

1 Background
2 Methodology of literature search
2.1 Positive search words (depending on search method)
2.2 Negative search words (depending on search method)
3 Number of hits
4 Relevance of publications
5 Literature search summary
6 Appropriate level of clinical evidence and strength of the evidence
7 Literature appraisal summary and conclusion

Other checklists for MDR/IVDR compliance

MDR technical documentation checklist

IVDR technical documentation checklist

Technical documentation checklist for medical device software (MDSW)

MDR-compliant quality system documentation checklist

MDR-compliant quality system documentation checklist for medical device software

Clinical Evaluation Plan checklist

Clinical Evaluation Report checklist

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Clinical Evaluation Plan checklist

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Useful information

CE-Certificate vs. EC-Certificate

Basic UDI-DI (bUDI)

EUDAMED registration - a brief guide

Authorised Representative Mandate

GSPR – General Safety and Performance Requirements

How to obtain CE marking for medical software under the EU MDR or IVDR?

Technical documentation for Medical Device Software in the EU

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Send us an email:
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Or use the contact form below

 

Solutions

EU Authorised Representative (EC REP)

EU PRRC

Technical documentation

Risk management

Clinical evaluation

Notified Bodies

Quality management system

Post-market surveillance

Resources

Medical Device Regulation (MDR) - basics

CE-marking process for medical devices

CE-marking process for in vitro diagnostic medical devices

MDR technical documentation checklist

IVDR technical documentation checklist

Technical documentation checklist for medical device software (MDSW)

MDR-compliant quality system documentation checklist

MDR-compliant quality system documentation checklist for medical device software

Clinical Evaluation Plan checklist

Clinical Evaluation Report checklist

PRRC under MDR or IVDR

Articles

CE-Certificate vs. EC-Certificate

Basic UDI-DI (bUDI)

EUDAMED registration - a brief guide

Authorised Representative Mandate

GSPR – General Safety and Performance Requirements

More articles >>

Devices

General medical devices and equipment

In vitro diagnostics (IVD)

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We only use essential cookies that enable core functionality and proper operation of the website. These cookies do not store any personally identifiable data. By continuing to use this website, you consent to the use of the essential cookies. You may disable these cookies by changing your browser settings, but this may affect how the website functions.
We do not use our own or third-party analytical, preferences, statistics, marketing, functional, advertisement, performance or any other non-essential cookies.