[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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[2025-09-23] (Open access) Delegated Regulation (EU) 2025/1920 on the unique identification of optical medical devices (spectacle frames, spectacle lenses and ready-to-wear reading spectacles) was published in the Official Journal of the European Union on September 23, 2025. It follows the public consultation we reported on earlier this year. We invite
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[2025-09-08] (Open access) The European Commission launched a call for evidence on September 8, 2025, to prepare a targeted revision of European regulations on medical devices (MD) and in vitro diagnostic medical devices (IVDD). The call for evidence is available in all European Union (EU) languages. You will need to
[2025-09-05] (Open access) Do you have a place at one of the upcoming EUDAMED workshops organized by the European Commission? The workshops, like the previous one held in Stuttgart on May 21, 2025, are free of charge, and always in a hybrid format: face-to-face and by videoconference. They will take
