MDCG 2020-13: Clinical evaluation assessment report template
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
MDCG 2020-5: Clinical Evaluation – Equivalence
Alle Leitfäden der Medical Device Coordination Group (MDCG) finden Sie HIER.