ARTICLES CONNEXESPLUS DE L'AUTEUR

DM DIV Europe

Europe – MDCG 2025-6 – FAQ on Interplay between the Medical Devices Regulation & In vitro Diagnostic Medical Devices Regulation and the Artificial Intelligence...

DM DIV Europe

Europe – MDCG 2025-5 Questions & Answers regarding performance studies of in vitro diagnostic medical devices under regulation (EU) 2017/746 June 2025

Practical guidance for procedures related to Brexit for medicinal products for human and veterinary use within the framework of the centralised procedure
DM DIV Europe

Europe – Update MDCG 2019-11 rev.1 – Qualification and classification of software – Regulation (EU) 2017/745 and Regulation (EU) 2017/746 (June 2025)

DM DIV Europe

UK – First major overhaul of medical device regulation comes into force across Great Britain

Opinion On Allergy Alert Test (AAT) as a proof-of-concept study
DM DIV Europe

Europe – MDCG 2025-4 Guidance on the safe making available of medical device software (MDSW) apps on online platforms

DM DIV Europe

UK – MHRA releases spate of new guidelines on decentralized manufacturing

DM DIV Amériques

USA – FDA issues guidance on transferring 510(k) ownership

CLASSIFICATION DES DM : Comparaison DDM/RDM
DM DIV Europe

Europe – EU plan would limit Chinese device makers in Europe

DM DIV Amériques

USA – FDA final guidance adds more details to Q-Sub program

DM DIV France

France – Nouvel avis sans recommandation de la Cnedimts sur le remboursement d’un DM de télésurveillance cardiaque

Practical guidance for procedures related to Brexit for medicinal products for human and veterinary use within the framework of the centralised procedure
DM DIV Europe

Europe – Study supporting the monitoring of the availability of medical devices on the EU market

ISO 14971 :2019 - GAP-ANALYSIS résumé versus l’ancienne version ISO EN FR 14971 : 2013.
DM DIV Amériques

USA – Medical Devices Regulatory Update / FDIS 10993-1 Released: Requirements and General Principles for the Evaluation of Biological Safety Within a Risk Management...