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Version 4 of the European manual on borderline and classification for medical devices and IVDs,
in Uncategorized
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MDCG issues version 4 of MDCG 2020-16: Guidance on Classification Rules IVDR,
in Uncategorized
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MDCG 2019-6 revision 5 issued: Q&A on requirements relating to notified bodies,
in Uncategorized
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IMDRF issues Characterization Considerations for Medical Device Software and Software-Specific Risk,
in Uncategorized
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MDCG 2021-12 FAQ on EMDN – Rev.1,
in Uncategorized
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MDCG 2024-2 Revision 1 published on Procedures for the updates of the European Medical Device Nomenclature,
in Uncategorized
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MDCG 2024-6, 7, 8 and 9 – Preliminary (re-)assessment review form templates published,
in Uncategorized
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MDCG issued 2023-3 Revision 2: Q&A on vigilance terms and concepts MDR-IVDR,
in Uncategorized
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MDCG publishes revision 1 of guidance (2022-3) concerning the verification of manufactured class D IVDs by notified bodies,
in Uncategorized
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Revision 1 issued of MDCG 2019-13 on sampling MDR and IVDR for the assessment of the technical documentation,
in Uncategorized
