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MDCG 2024-6, 7, 8 and 9 – Preliminary (re-)assessment review form templates published,
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MDCG issued 2023-3 Revision 2: Q&A on vigilance terms and concepts MDR-IVDR,
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MDCG publishes revision 1 of guidance (2022-3) concerning the verification of manufactured class D IVDs by notified bodies,
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Revision 1 issued of MDCG 2019-13 on sampling MDR and IVDR for the assessment of the technical documentation,
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European Commission issued a Q&A on Gradual Roll-out of EUDAMED,
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European Commission issues Q&A on Article 10a of the MDR/IVDR,
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MDCG 2022-5 Rev. 1 published on (MDR) borderline products: medical devices and medicinal products,
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MDCG issued 2024-13 on regulatory status of EtO,
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MDCG 2021-25 Rev.1 report issued on transitional provisions,
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Current status MDR / IVDR Notified Bodies,
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