Regulatory and standards Flash

Team-NB: “1st EU Regulations Discussion Day”.

[2025-09-19] (Open access) Team-NB (The European Association of Medical devices Notified Bodies) announces its 1st EU Regulations Discussion Day 2025. This event is aimed at small and medium-sized enterprises (SMEs), members of notified bodies and organizations. It aims to encourage exchanges between stakeholders on the future European regulatory framework for

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European Commission: EUDAMED workshops

[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

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European Commission: call for evidence on MDR and IVDR

[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

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REACh: new restrictions on substances D4, D5 and D6

[2025-09-17] REACh (Registration, Evaluation, Authorization and restriction of Chemicals) is the European regulation governing the registration, evaluation, authorization and restriction of chemical substances. It applies…contenu réservé à nos abonnés Premium

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HAS: CNEDiMTS assessment principles

[2025-07-01] The Haute Autorité de Santé (HAS) website, which provides information on the evaluation of medical devices (MDs) for reimbursement purposes, was updated on July…contenu réservé à nos abonnés Premium

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