Medical Devices Regulation
Joint Statement
Medical Devices
Medical Devices Regulation
Open letter to the European Commission: protecting Europe’s medical technology sector from the risks of tariffs
Joint Statement
Medical Devices
Medical Devices Regulation
Article 10a MDR / IVDR: Notification in Case of Interruption or Discontinuation of Supply – Decision Guide Flowchart
Medical Devices Regulation
Statement
AESGP Statement on the European Parliament’s Call to Urgently Revise the Medical Devices Regulation
Medical Devices Regulation
Statement
AESGP Statement on Regulation (EU) 2024/1860 amending the IVDR and MDR
Medical Devices
Medical Devices Regulation
White Paper
Not all is well in the state of MDR: AESGP releases White Paper on MDR Regulatory Framework
Market Data
Medical Devices Regulation
Press release
MDR Implementation Challenges could impact 40% of consumer healthcare market
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
Medical Devices Regulation
Statement
AESGP Statement on the European Commission’s legislative proposal amending the IVDR and MDR
Medical Devices
Medical Devices Regulation
Medical Devices: Industry publishes Manufacturer’s Declaration in relation to Regulation (EU) 2023/607
Medical Devices
Medical Devices Regulation
Statement
AESGP welcomes MDR amendment and highlights need to tackle MDR systemic issues
Medical Devices
Medical Devices Regulation
Statement
Statement on European Commission’s legislative proposal amending the MDR
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)
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
Medical Devices
Medical Devices Regulation
Statement