Module 15 Presentations

4/15/2024

MDCG Guidance – Clinical Investigation and Evaluation

Reference

Title

Publication December 2023 March 2024 March 2024 December 2023 May 2023 December 2021 July 2021 May 2021 December 2023

Guidance on demonstration of equivalence for Annex XVI products - A guide for manufacturers and notified bodies Guidance on content of the Clinical Investigation Plan for clinical investigations of medical devices Clinical Investigation Plan Synopsis Template Guidance on exemptions from the requirement to perform clinical investigations pursuant to Article 61(4)-(6) MDR and on sufficient levels of access’ to data needed to justify claims of equivalence Commission Guidance on the content and structure of the summary of the clinical investigation report

MDCG 2023-6

MDCG 2024-3 MDCG 2024-3 Appendix A

MDCG 2023-7

2023/C 163/06

MDCG 2021-28

Substantial modification of clinical investigation under Medical Device Regulation

MDCG 2021-20 MDCG 2021-8

Instructions for generating CIV-ID for MDR Clinical Investigations Clinicalinvestigationapplication/notification documents

MDCG 2021-6 - Rev.1

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

MDCG 2020-13 - Word version MDCG 2020-10/1 Rev.1MDCG 2020-10/2 Rev. 1

Clinical evaluation assessment report template

July 2020

October 2022 October 2022

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

MDCG 2020-8 MDCG 2020-7

Guidance on PMCF evaluation report template

April 2020 April 2020

Guidance on PMCF plan template

Guidance on sufficient clinical evidence for legacy devices Background note on the relationship between MDCG 2020-6 and MEDDEV 2.7/1 rev.4 on clinical evaluation

MDCG 2020-6

April 2020

MDCG 2020-5

Guidance on clinical evaluation – Equivalence

April 2020

© NAMSA 2021 MDCG 2019-9 - Rev.1

Summary of safety and clinical performance

21 March 2022

21

EUDAMED Database

EUDAMED

• IT system for implementation of theMDR and IVDR • 6 modules and a public website:

• Actors registration

December 2020

• UDI/Devices registration

October 2021

• Notified Bodies and Certificates

October 2021

• Clinical Investigations and performance studies

Under development

• Vigilance and post-market surveillance

Under development

• Market Surveillance

Under development

• EUDAMED public

Under development

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© NAMSA 2021

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