On Clinical Investigation and Evaluation:
MDCG 2020-13 on clinical evaluation assessment report. CEAR is a report used by the notified body to 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 (July 2020).
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)
MDCG 2019-9 on Summary of safety and clinical performance. A guide for manufacturers and notified bodies (August 2019)
On New Technologies:
MDCG 2020-1 on Guidance on Clinical Evaluation (MDR) / Performance Evaluation (IVDR) of Medical Device Software (March 2020)