Medical Devices Regulation

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

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

January 09, 2023

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)

“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

January 18, 2022

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