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Europe – European Commission approves ustekinumab for paediatric Crohn’s disease
The European Commission (EC) has approved ustekinumab for the treatment of moderately to severely active Crohn’s disease in paediatric patients weighing at least 40...
UK – Clinical investigations of medical devices – guidance for manufacturers
It is important to note that the rules for notifying the MHRA of a clinical investigation in
Great Britain (England, Wales and Scotland) differ from...
Europe – MDCG 2022-3 rev.1 – Verification of manufactured class D...
Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) establishes
the requirements for notified bodies involved in the conformity assessment of applicable classes of...
France – L’IA en santé, un enjeu majeur pour la HAS...
L’effervescence des nouvelles technologies de santé et la montée en puissance de l’intelligence artificielle (IA) en santé sont autant d’opportunités pour améliorer la qualité...
