Module 15 2022

5/19/2022

Clinical Data requirements overview

MDR

Key sections of the MDR for Clinical data: • Chapter I Scope and definitions • Chapter VI

Clinical Evaluation and clinical investigations

• Annex XIV • Annex XV

Clinical Evaluation and PMCF

Clinical Investigations

Guidance on Clinical Data: • MDCG 2020-5 Equivalence • MDCG 2020-6 Sufficient clinical data for legacy devices

• MDCG 2020-7 PMCF Plan • MDCG 2020-8 PMCF Report • MDCG 2020-13 Clinical evaluation assessment report (Notified Body Review)

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The UK

© NAMSA 2021

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