Europe- MDCG 2019-6 Rev5 Questions and answers: Requirements relating to notified bodies
Guidance documents are by definition not compulsory. However, all guidance
documents endorsed by the MDCG reflect the interpretation of the EU law jointly
agreed by the...
Europe – European Commission announces pilot for coordinated assessment of clinical investigations
EU Member States have launched a pilot program to accept single applications for the assessment of clinical investigations and performance studies, coordinated by the...
Europe – EMA establishes regular procedure for scientific advice on certain high-risk medical devices
EMA, in close collaboration with the European Commission, has established a standard procedure for manufacturers of certain high-risk medical devices to request scientific advice on their...
Europe – Règlement D’exécution (UE) 2025/117 de la Commission du 24 janvier 2025
LA COMMISSION EUROPÉENNE,
vu le traité sur le fonctionnement de l’Union européenne,
vu le règlement (UE) 2021/2282 du Parlement européen et du Conseil du 15 décembre...
Europe – Revised versions and new guidance are available in the EMDN section
MDCG 2025-1 EMDN Ad hoc procedure January 2025
MDCG 2025-2 Summary of EMDN 2024 Submissions and outcome of annual revision January 2025
MDCG 2025-3 EMDN Version...
UK – MHRA guidance on new Medical Devices Post-Market Surveillance requirements
A suite of guidance has been published by the Medicines and Healthcare products Regulatory Agency (MHRA). This guidance is designed to help medical device manufacturers...
UK – Implementation of medical devices future regime
The government intends to introduce new regulations for medical devices that prioritise patient safety, give patients access to the medical devices they need and...
Europe – MDCG 2024-8 Rev. 1 Preliminary assessment review template – ...
This document has been endorsed by the Medical Device Coordination Group (MDCG) established by Article 103 of Regulation (EU) 2017/745. The MDCG is composed...
Europe – MDCG 2024-7 Rev. 1 Preliminary assessment review template – MDR...
This document has been endorsed by the Medical Device Coordination Group (MDCG) established by Article 103 of Regulation (EU) 2017/745. The MDCG is composed...
Europe – MDR Certification Process (including Pre-application, Application and Post Application phases) – Consensus...
The purpose of this consensus document is to describe in detail the pre-application, application processes through which manufacturers may apply to Notified Bodies (NBs)...
