Background note on the relationship between MDCG 2020-6 and MEDDEV 2.7/1 rev. 4 on clinical evaluation

MDCG 2020-6 document Regulation (EU) 2017/745: Clinical evidence needed for medical devices previously CE marked under Directives 93/42/EEC or 90/385/EEC – A guide for manufacturers and notified bodies, references in Appendix I the sections of MEDDEV 2.7/1 rev. 4 which are still relevant under the MDR for the application of the MDCG 2020-6.

Appendix I – Sections of MEDDEV 2.7/1 rev. 4 which are still relevant under the MDR for the application of this guidance

 6.4. Who should perform the clinical evaluation?
 8. Identification of pertinent data (Stage 1)
 9. Appraisal of pertinent data (Stage 2)
 10. Analysis of the clinical data (Stage 3). This chapter includes references to the MDD, MDR requirements should be used instead
 A3. Device description – typical contents
 A4. Sources of literature
 A5. Literature search and literature review protocol, key elements
 A6. Appraisal of clinical data – examples of studies that lack scientific validity for demonstration of adequate clinical performance and/or clinical safety
 A7.2. Conformity assessment with requirement on acceptable benefit/risk profile
 A7.3. Conformity assessment with requirement on performance
 A7.4. Conformity assessment with requirements on acceptability of undesirable side-effects
 A10. Proposed checklist for the release of the clinical evaluation report.

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