Medical Devices Regulation

MDR Implementation Challenges could impact 40% of consumer healthcare market
Market Data Medical Devices Regulation Press release

MDR Implementation Challenges could impact 40% of consumer healthcare market

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

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

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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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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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