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.