The European Commission also released this morning 4 important MDCG documents covering PMCF, namely template for a Plan and Report and guide on equivalence and clinical evidence for legacy devices:
- Post-market clinical follow-up (PMCF) Evaluation Report Template. A guide for manufacturers and notified bodies (MDCG)
- Post-market clinical follow-up (PMCF) Plan Template. A guide for manufacturers and notified bodies (MDCG)
- Clinical Evaluation – Equivalence. A guide for manufacturers and notified bodies (MDCG)
- 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)
All the documents can be found in our Library of Documents, under icon CLINICAL EVALUATION and MDCG.
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