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AESGP

MDR/IVDR

AESGP White Paper: Lessons learned with the MDR Implementation (2024) View
MDR/IVDR

AESGP White Paper: Lessons learned with the MDR Implementation (2024)

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IQVIA Consumer Health x AESGP White Paper View
MDR/IVDR

IQVIA Consumer Health x AESGP White Paper "Dynamics of Self-Care Medical Devices in Europe" (2024)

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Joint statement supporting the expansion of the use of Electronic Instructions For Use (eIFU) in the medical devices sector (2024) View
MDR/IVDR

Joint statement supporting the expansion of the use of Electronic Instructions For Use (eIFU) in the medical devices sector (2024)

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AESGP Statement on the European Commission’s legislative proposal amending the IVDR and MDR (2024) View
MDR/IVDR

AESGP Statement on the European Commission’s legislative proposal amending the IVDR and MDR (2024)

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Joint open letter: In anticipation of EUDAMED availability for mandatory use (2023) View
MDR/IVDR

Joint open letter: In anticipation of EUDAMED availability for mandatory use (2023)

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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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