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1,129 resources

MDCG 2022-11: Notice to manufacturers to ensure timely MDR/IVDR compliance

MDCG Guidance 2023-11 MDCG Guidance Other / Transition
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MDCG 2021-25: Application of MDR requirements to legacy devices placed on market prior to 26 May 2021

MDCG Guidance 2024-10 MDCG Guidance Other / Transition
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MDCG 2021-5: Guidance on standardisation for medical devices

MDCG Guidance 2024-07 MDCG Guidance Standards
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MDCG 2020-3: Guidance on significant changes regarding transitional provision under Article 120 of MDR

MDCG Guidance 2023-09 MDCG Guidance Notified Bodies
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MDCG 2024-12: CAPA plan assessment: guidance and templates for conformity assessment bodies

MDCG Guidance 2024-10 MDCG Guidance Notified Bodies
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MDCG 2022-4: Guidance on appropriate surveillance regarding transitional provisions under Article 120 of MDR

MDCG Guidance 2024-05 MDCG Guidance Notified Bodies
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MDCG 2019-6: Q&A: Requirements relating to notified bodies

MDCG Guidance 2025-02 MDCG Guidance Notified Bodies
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MDCG 2021-1: Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional

MDCG Guidance 2021-05 EUDAMED MDCG Guidance
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MDCG 2022-12: Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional (IVDR)

MDCG Guidance 2022-07 EUDAMED MDCG Guidance
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MDCG 2018-1: Guidance on basic UDI-DI and changes to UDI-DI

MDCG Guidance 2021-04 MDCG Guidance UDI
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