Medical Devices

Joint discussion paper on Future governance of medical technologies in Europe (2025) View
Medical Devices

Joint discussion paper on Future governance of medical technologies in Europe (2025)

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Article 10a MDR / IVDR: Notification in Case of Interruption or Discontinuation of Supply – Decision Guide Flowchart (2025) View
Medical Devices

Article 10a MDR / IVDR: Notification in Case of Interruption or Discontinuation of Supply – Decision Guide Flowchart (2025)

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Joint Paper on Clinical strategy as part of pre-submission dialogue between manufacturer and Notified Body (2025) View
Medical Devices

Joint Paper on Clinical strategy as part of pre-submission dialogue between manufacturer and Notified Body (2025)

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AESGP Statement on the European Parliament’s Call to Urgently Revise the Medical Devices Regulation (2024) View
Medical Devices

AESGP Statement on the European Parliament’s Call to Urgently Revise the Medical Devices Regulation (2024)

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AESGP Statement on Regulation (EU) 2024/1860 amending the IVDR and MDR (2024) View
Medical Devices

AESGP Statement on Regulation (EU) 2024/1860 amending the IVDR and MDR (2024)

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

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

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IQVIA Consumer Health x AESGP White Paper View
Medical Devices

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
Medical Devices

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
Medical Devices

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
Medical Devices

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
Medical Devices

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
Medical Devices

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
Medical Devices

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
Medical Devices

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
Medical Devices

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

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

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

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