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...
France – Accès dérogatoire pour un dispositif médical dépourvu de marquage CE : optimisation...
À partir du 27 janvier 2025, les industriels qui souhaitent demander un accès dérogatoire pour mettre sur le marché des dispositifs médicaux dépourvus de...
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...
France – Endométriose : le gouvernement annonce le remboursement de tests salivaires pour certaines...
La ministre de la santé, Catherine Vautrin, a annoncé, lundi 10 février, qu’un test salivaire utilisé pour le diagnostic de l’endométriose, encore au stade expérimental,...
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...
USA – Drug, device makers scramble for tariff exemptions, warn of supply disruptions
Drug and device manufacturers are raising concerns about President Donald Trump’s tariffs on imports from China, Mexico, and Canada, warning that they could worsen...
International – IMDRF finalizes good machine learning practice, software risk documents
The International Medical Device Regulators Forum (IMDRF) on Wednesday finalized two highly anticipated technical documents detailing guiding principles for good machine learning practices (GMLP)...
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...
