Amending regulation for postponing #MDR DoA for one year (i.e. May 2021) published in the Official Journal.
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2. MDCG publishes as series of Guidances on Clinical investigations and Evaluations:
-MDCG 2020-8: Post-market clinical follow-up (PMCF) Evaluation Report Template. A guide for manufacturers and notified bodies.
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-MDCG 2020-7: Post-market clinical follow-up (PMCF) Plan Template. A guide for manufacturers and notified bodies.
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-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.
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-MDCG 2020-5 Clinical Evaluation – Equivalence. A guide for manufacturers and notified bodies.
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