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Karim Chelly

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Proposed simplification of MDR and IVDR

2026-01-09

[2025-12-16] (Open access) The European Commission adopted on December 17, 2025 a proposal to simplify regulations (EU) 2017/745 for medical devices (MDR) and (EU) 2017/746 for in vitro diagnostic medical devices (IVDR). Expected like the Messiah by the entire industry (and almost on time for Christmas), this proposal to simplify

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FDA : FAQ on QMSR

2025-10-01
[2025-08-27] In February 2024, the US Food and Drug Administration (FDA) published its final rule on the transition from the QSR (QS Regulation) to the…contenu réservé à nos abonnés Premium

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