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International – WHO guideline aims to facilitate the development of “more...
The World Health Organization (WHO) has released a draft guideline to encourage the development of better-formulated and higher-quality pediatric medicines. The guideline targets member...
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...
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 – Dépakine : la justice confirme que l’Etat est en...
La cour administrative d’appel de Paris a confirmé mardi que l'État avait une part de responsabilité dans l'"insuffisance d'information" donnée aux patients et aux médecins sur...
