Medical Devices

Not all is well in the state of MDR: AESGP releases White Paper on MDR Regulatory Framework
Medical Devices Medical Devices Regulation White Paper

Not all is well in the state of MDR: AESGP releases White Paper on MDR Regulatory Framework

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Joint statement supporting the expansion of the use of Electronic Instructions For Use (eIFU) in the medical devices sector
Joint Statement Medical Devices Medical Devices Regulation

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

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Joint open letter: In anticipation of EUDAMED availability for mandatory use
Joint Statement Letter Medical Devices

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

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

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

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AESGP welcomes MDR amendment and  highlights need to tackle MDR systemic issues
Medical Devices Medical Devices Regulation Statement

AESGP welcomes MDR amendment and highlights need to tackle MDR systemic issues

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Statement on European Commission’s legislative proposal amending the MDR
Medical Devices Medical Devices Regulation Statement

Statement on European Commission’s legislative proposal amending the MDR

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

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

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“Substance-Based Medical Devices: Regulatory Challenges and Prospects”, a new TOPRA article by AESGP
AESGP in the Media Medical Devices Medical Devices Regulation Scientific Article

“Substance-Based Medical Devices: Regulatory Challenges and Prospects”, a new TOPRA article by AESGP

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AESGP Annual Report 2020
Annual Report Brexit Environment Food supplements Medical Devices OTC Self-care

AESGP Annual Report 2020

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Statement on the Medical Devices Regulation's date of application
Medical Devices Medical Devices Regulation Statement

Statement on the Medical Devices Regulation's date of application

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Joint Industry Letter on EU Standardisation Policy
Letter Medical Devices

Joint Industry Letter on EU Standardisation Policy

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Position Paper on Rule 21 of the MDR
Medical Devices Position paper

Position Paper on Rule 21 of the MDR

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AESGP Annual Report 2019
Annual Report Brexit Environment Food supplements Medical Devices OTC Self-care

AESGP Annual Report 2019

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AESGP and the COVID-19 pandemic
COVID-19 Medical Devices OTC Self-care

AESGP and the COVID-19 pandemic

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AESGP Regulatory Conference (Oct. 2019) - report published
Conference report EMA Food supplements Incentives Medical Devices OTC Self-care

AESGP Regulatory Conference (Oct. 2019) - report published

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AESGP Annual Report 2018
Annual Report Environment Food supplements Medical Devices OTC Self-care

AESGP Annual Report 2018

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Position on the implications of the UK exit from the European Union
Brexit EMA Medical Devices OTC Position paper Self-care

Position on the implications of the UK exit from the European Union

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Position Paper on Rule 14 of the MDR
Medical Devices Position paper

Position Paper on Rule 14 of the MDR

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AESGP Annual Report 2017-2018
Annual Report Environment Food supplements Medical Devices OTC Self-care

AESGP Annual Report 2017-2018

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AESGP Annual Report 2016-2017
Annual Report Environment Food supplements Medical Devices OTC Self-care

AESGP Annual Report 2016-2017

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AESGP Annual Report 2015-2016
Annual Report Environment Food supplements Medical Devices OTC Self-care

AESGP Annual Report 2015-2016

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