Module 15 2022

5/19/2022

Medical Device Co-ordination Group (MDCG) Guidance

• Borderline and Classification • Class I Devices • Clinical investigation and evaluation • COVID-19 • Custom-Made Devices • EUDAMED • European Medical Device Nomenclature (EMDN) • Implant cards • Importers & Distributors • In Vitro Diagnostic medical devices (IVD) • New technologies • Notified bodies • Standards • Unique Device Identifier (UDI) • Other topics

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MDCG Guidance – Clinical Investigation and Evaluation

Reference

Title

Publication December 2021 July 2021 May 2021

Substantial modification of clinical investigation under Medical Device Regulation

MDCG 2021-28

MDCG 2021-20 Instructions for generating CIV-ID for MDR Clinical Investigations MDCG 2021-8 Clinical investigation application/notification documents

Regulation (EU) 2017/745 – Questions & Answers regarding clinical investigation

MDCG 2021-6

April 2021

MDCG 2020-13 Clinical evaluation assessment report template

July 2020

MDCG 2020 10/2 MDCG 2020 10/1

Guidance on safety reporting in clinical investigations Appendix: Clinical investigation summary safety report form

May 2020 May 2020

MDCG 2020-8 Guidance on PMCF evaluation report template

April 2020 April 2020 April 2020 April 2020

MDCG 2020-7 Guidance on PMCF plan template

MDCG 2020-6 Guidance on sufficient clinical evidence for legacy devices MDCG 2020-5 Guidance on clinical evaluation – Equivalence

MDCG 2019-9 - Rev.1

Summary of safety and clinical performance

March 2022

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