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European Commission issued a Q&A on Gradual Roll-out of EUDAMED,
in Uncategorized
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European Commission issues Q&A on Article 10a of the MDR/IVDR,
in Uncategorized
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MDCG 2022-5 Rev. 1 published on (MDR) borderline products: medical devices and medicinal products,
in Uncategorized
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MDCG issued 2024-13 on regulatory status of EtO,
in Uncategorized
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MDCG 2021-25 Rev.1 report issued on transitional provisions,
in Uncategorized
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Current status MDR / IVDR Notified Bodies,
in Uncategorized
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Call to medical device manufacturers: implement an effective PMS system,
in Uncategorized
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MDCG issued 2024-11 on qualification of in vitro diagnostic medical devices,
in Uncategorized
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MDCG 2021-4 Q&A on how to handle class D IVDs during transition to IVDR – revision 1,
in Uncategorized
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Revision 2 of MDR and IVDR language requirements for manufacturers published,
in Uncategorized
