Regulatory and Standards Flash

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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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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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: new update of the manual on borderline products and classification of MDs and IVDDs

[2025-09-12] In September 2025, the European Commission's Borderline and Classification Working Group published a further update of the reference document on borderline products and classification…contenu réservé à nos abonnés Premium

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