Australia – Update: Medical device UDI implementation, Essential Principles guidance
The Therapeutic Goods Administration (TGA), Australia’s medical device market regulatory entity, has issued several updates regarding Unique Device Identification (UDI) regulations, Essential Principles compliance...
France – HAS – CNEDiMTS : DEPREXIS (thérapie numérique): service attendu suffisant dans la...
DEPREXIS est un dispositif médical interactif accessible en ligne par l’intermédiaire de tout accès à Internet (ordinateur, smartphone ou tablette avec navigateur compatible). C’est...
France – Surveillance des infections associées aux dispositifs invasifs en 2020
Santé publique France publie les résultats de la 2e édition de la mission nationale SPIADI menée entre le 1er janvier et le 15 juillet...
Europe – MDCG 2022-4 Rev.1 Guidance on appropriate surveillance regarding the transitional provisions under...
Article 120(2) and 120(3) of the Medical Device Regulation (EU) 2017/745 (MDR) state that
devices which are covered by valid certificates issued by a notified...
USA – Lasers: FDA publishes guidance on surveying, leveling and alignment products
The US Food and Drug Administration (FDA) has finalized a 2014 guidance that lays out its thinking what is and isn’t a regulated laser...
France – Solutions d’informatique embarquée pour les DM à base d’IA
Le big data, l'apprentissage automatique (Machine Learning) et l'intelligence artificielle (IA) permettent d'obtenir des informations approfondies en analysant de grandes quantités de données issues...
Europe – MDCG 2023-5 – Guidance on qualification and classification of Annex XVI products...
The Regulation (EU) 2017/745 on medical devices, hereafter referred to as the MDR, is applicable to the groups of products without an intended medical...
China – Un robot miniature biodégradable pour l’administration ciblée de médicaments
La libération ciblée de médicaments aux emplacements souhaités est difficile dans le tractus gastro-intestinal en raison de l'environnement acide/alcalin de l'estomac et des intestins,...
UK – Guidance : Software and AI as a Medical Device Change Programme
Software (and AI in particular) plays an increasingly prominent role in health systems, having a wide set of applications across health and social care....
USA – FDA rules on definitions of device; issues revised form for reporting adverse...
The US FDA has issued final guidance clarifying how the agency interprets existing references to section 201(h) of the FD&C Act and how the agency intends...
