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May 22, 2024
The Medical Device Coordination Group (MDCG) published the new 2024-3 guidance document relating to clinical investigations of medical devices. How...
January 24, 2024
The European Commission proposed on 23 January more time for companies to apply the In Vitro Diagnostic Medical Devices Regulation (IVDR), under certain conditions, as well as measures to enhance transparency in the medical device sector including speeding up the launch of some elements of the European Database on Medical Devices - EUDAMED.
November 24, 2023
This digest covers key virtual and digital health regulatory and public policy developments during October 2023 from the United States, United Kingdom, and European Union.
November 24, 2023
This digest covers key virtual and digital health regulatory and public policy developments during October 2023 from the United States, United Kingdom, and European Union.
May 22, 2023
This edition of Vital Signs is filled with digital health developments from around the world. In Industry Insights, you'll see and hear from Alexis Gilroy and Claire Castles...
February 21, 2023
On Thursday, the EU Parliament approved the European Commissionโs proposal to extend the transition periods of the Medical Device Regulation (EU) 2017/745 (MDR). As the Council had...
January 21, 2023
From patient-centricity in a connected world to holistic sustainability strategies and proposed MDR amendments, hear what consultants have to say about the changing medical device landscape in 2023.
January 18, 2023
Following up on its announcement in the EU Employment, Social Policy, Health and Consumer Affairs Council (EPSCO) Meeting, the European Commission (Commission) released on January 6,...
January 10, 2023
The European Commission adopted on 6 January a proposal to give more time to certify medical devices to mitigate the risk of shortages.