Regulatory Repository
REGULATIONS
European Union Medical Device Regulation (EU MDR)
2017
Clinical Evaluation
MDCG 2020-1
Guidance on Clinical Evaluation (MDR) / Performance Evaluation (IVDR) of Medical Device Software
March 2020
MDCG 2020-5
Clinical Evaluation – Equivalence
A guide for manufacturers and notified bodies
April 2020
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
April 2020
MDCG 2020-13
Clinical evaluation assessment report
July 2020
MDCG 2024-10
Clinical evaluation of orphan medical devices
June 2024
A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES UNDER DIRECTIVES 93/42/EEC and 90/385/EEC
June 2016
Background note on the relationship between MDCG 2020-6
and MEDDEV 2.7/1 rev. 4 on clinical evaluation
July 2020
Post Market Clinical Follow-Up
MDCG 2020-7
Post-market clinical follow-up (PMCF) Plan Template A guide for manufacturers and notified bodies
April 2020
MDCG 2020-8
Post-market clinical follow-up (PMCF) Evaluation Report Template A guide for manufacturers and notified bodies
April 2020
Post Market Surveillance
MDCG 2022-21
Guidance on periodic safety update report (PSUR) According to regulation (EU) 2017/745 (MDR)
December 2022
Clinical Investigation
COMMISSION GUIDANCE
on the content and structure of the summary of the clinical investigation report
8.5.2023
MDCG 2021-6 Rev. 1
Regulation (EU) 2017/745 –
Questions & Answers regarding clinical investigation
December 2023
MDCG 2021-08
Clinical investigation application/notification documents
May 2021
MDCG 2021-20
Instructions for generating CIV-ID
for MDR Clinical Investigations
July 2021
MDCG 2021-28
Substantial modification of clinical investigation under Medical Device Regulation
December 2021
MDCG 2023-7
Guidance on exemptions from the requirement to perform clinical investigations pursuant to Article 61(4)-(6) MDR
December 2023
MDCG 2024-3
Guidance on content of the Clinical Investigation Plan for clinical investigations of medical devices
March 2024
Medical Device
Coordination Group Document
MDCG 2024-3
2024
MDCG 2024-5
guidance on content of the Investigator’s Brochure for clinical investigations of medical devices
April 2024
Medical Device Coordination Group Document MDCG 2024-5
2024
Summary of Safety and Performance
MDCG 2019-9 Rev.1
Summary of safety and clinical performance A guide for manufacturers and notified bodies
March 2022
MDCG 2021-20
Instructions for generating CIV-ID
for MDR Clinical Investigations
July 2021