Quatre nouveaux guides MDCG

Le groupe MDCG vient de publier quatre nouveaux guides :

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