The European Commission’s Medical Device Coordination Group (MDCG) on Friday posted five new guidances on demonstrating equivalence to existing devices; clinical evidence for legacy devices; templates for postmarket clinical follow-up plans and evaluation reports; and regulatory requirements for ventilators.

 

MDCG 2020-5 Clinical Evaluation – Equivalence. 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 bodies
 
MDCG 2020-7 Post-market clinical follow-up (PMCF) Plan Template. A guide for manufacturers and notified bodies
 
MDCG 2020-8 Post-market clinical follow-up (PMCF) Evaluation Report Template. A guide for manufacturers and notified bodies
 
MDCG 2020-9 Regulatory Requirements for Ventilators and Related Accessories