MDCG 2020-10/1 Safety reporting in clinical investigations of medical devices under the Regulation (EU) 2017/745
Posts published in “MDCG – Medical Devices Coordination Group”
MDCG 2020-10/2 Clinical Investigation Summary Safety Report Form v1.0
Ongoing Guidance development within MDCG Subgroups
MDCG 2020-9 Regulatory Requirements for Ventilators and Related Accessories
MDCG 2020-8 Post-market clinical follow-up (PMCF) Evaluation Report Template. A guide for manufacturers and notified bodies
MDCG 2020-7 Post-market clinical follow-up (PMCF) Plan Template. A guide for manufacturers and notified bodies
MDCG 2020-6 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…
MDCG 2020-5 Clinical Evaluation – Equivalence. A guide for manufacturers and notified bodies
MDCG 2019-3 Interpretation of Article 54(2)b rev 1
Planned meetings of Medical Device Coordination Group (MDCG) and subgroups in 2020