MDCG New Guidances

On Clinical Investigation and Evaluation:

MDCG 2020-5 on Clinical Evaluation – Equivalence. A guide for manufacturers and notified bodies (April 2020).

MDCG 2020-6 on (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 (April 2020).

MDCG 2020-7 on Post-market clinical follow-up (PMCF) Plan Template. A guide for manufacturers and notified bodies (April 2020).

MDCG 2020-8 on Post-market clinical follow-up (PMCF) Evaluation Report Template. A guide for manufacturers and notified bodies (April 2020).

MDCG 2020-10/1 and MDCG 2020-10/2 Guidance on safety reporting in clinical investigations
Appendix: Clinical investigation summary safety report form (May 2020)

On New Technologies:

MDCG 2020-1 on Guidance on Clinical Evaluation (MDR) / Performance Evaluation (IVDR) of Medical Device Software (March 2020).