Europe – Règlement d’exécution (UE) 2023/1194 de la Commission du 20 juin 2023 modifiant...
Est paru le 21 juin 2023 au Journal Officiel de l’Union Européenne le Règlement d’exécution (UE) 2023/1194 modifiant les dispositions transitoires établies dans le Règlement...
USA – FDA drafts guidance to aid orthopedic implant guide makers
The US Food and Drug Administration (FDA) has issued draft guidance that outlines its expectations from sponsors filing premarket submissions for patient-matched guides used...
France – L’ANSM demande aux fabricants de dispositifs médicaux qui envoient un avis de...
Des concertations menées par l’ANSM avec des pharmaciens qui distribuent ou utilisent des dispositifs médicaux ou dispositifs médicaux de diagnostic in vitro, montrent que la...
Europe – EUDAMED user guide : Economic Operators – Actor module
EUDAMED is the IT system developed by the European Commission to implement the EU
medical devices regulations:
Regulation 2017/745 on medical devices
Regulation 2017/746 on in vitro...
USA – Content of Premarket Submissions for Device Software Functions
This guidance document is intended to provide information regarding the recommended documentation for premarket submissions for FDA’s evaluation of the safety and effectiveness of...
Europe – MedTech Europe signs joint healthcare statement highlighting how the AI Act can...
In the joint statement, healthcare stakeholders representing patients, healthcare professionals and industry, share their views on how the AI Act can give citizens the...
Australia – New guidance published on manufacturer evidence for IVD medical devices
We no longer accept ISO 13485 certificates to support applications for new In Vitro Diagnostic (IVD) medical devices, except if the manufacturer made a...
UK – MHRA issues new guidance on the use of life saving adrenaline auto-injectors
The Medicines and Healthcare products Regulatory Agency (MHRA) has launched new guidance to highlight the latest safety advice on the steps to take during...
USA – FDA revamps device software premarket submissions guidance
The US Food and Drug Administration (FDA) this week finalized guidance on the content of premarket submission for software functions in medical devices. The...
USA – Joint FDA/VHA medical device pilot aims to create digital stockpiles, bolster distributed...
The US Food and Drug Administration (FDA) and the Veterans Health Administration (VHA) have formed a partnership aimed at curbing medical device shortages. A 22...
