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AESGP

MDR/IVDR

Medical Devices - Manufacturer’s Declaration in relation to Regulation (EU) 2023/607 View
MDR/IVDR

Medical Devices - Manufacturer’s Declaration in relation to Regulation (EU) 2023/607

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AESGP Statement on European Commission’s legislative proposal amending the MDR (2023) View
MDR/IVDR

AESGP Statement on European Commission’s legislative proposal amending the MDR (2023)

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AESGP Statement on the MDCG Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices (MDCG 2022 – 5) (2022) View
MDR/IVDR

AESGP Statement on the MDCG Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices (MDCG 2022 – 5) (2022)

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AESGP Statement on the Medical Devices Regulation's date of application (2021) View
MDR/IVDR

AESGP Statement on the Medical Devices Regulation's date of application (2021)

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AESGP Position Paper on Classification Rule 21- MDR (2020) View
MDR/IVDR

AESGP Position Paper on Classification Rule 21- MDR (2020)

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AESGP Position Paper on Classification Rule 14 - MDR (2018) View
MDR/IVDR

AESGP Position Paper on Classification Rule 14 - MDR (2018)

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