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Europe – EMA spells out data access policy for shortage monitoring...
On Monday, the European Medicines Agency (EMA) issued a new data access policy, elaborating on the differing levels of data access available to different...
Europe – Urgent call for clarity on clinical strategy discussions
MedTech Europe, AESGP, MedTech & Pharma Platform and COCIR would like to express their concerns that the recently updated MDCG 2019-6: Requirements relating to notified bodies...
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...
International – Un Australien devient le tout premier patient à quitter...
L'homme, qui souffrait d'une grave insuffisance cardiaque, a en effet vécu avec le BiVACOR Total Artificial Heart (TAH), une pompe à sang en titane,...
