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NEWS

News in Brief

The EU’s standardisation guidance MDCG 2021-5 has been updated

August 14, 2024
News in Brief

News and publications from the European Commission

August 12, 2024
Important Notice

Draft manufacturer self-declaration and notified body confirmation letter for Regulation (EU) 2024/1860 available

August 9, 2024
Important Notice

When is a medical device impacted by the AI Act?

August 6, 2024
News in Brief

EU guidelines for justifying phthalates in medical devices updated

July 26, 2024
Important Notice

AI Act published in OJEU

July 12, 2024
News in Brief

European Commission guidance publication update

July 12, 2024
Important Notice

Amending Regulation (EU) 2024/1860 published in the OJEU

July 10, 2024
Brexit

MHRA draft recognition policy for international approvals

June 22, 2024
News in Brief

BSI first notified body to officially publish lead times under EU Medical Devices Regulations

June 14, 2024
Important Notice

European Parliament initiative for MDR improvement

June 12, 2024
News in Brief

Update of MDCG 2022-4

June 10, 2024
Important Notice

Extension of IVDR transition periods and early launch of Eudamed takes last hurdle

May 31, 2024
News in Brief

European Commission publication update

May 3, 2024
News in Brief

Free scientific advice for high-risk devices

April 29, 2024
Brexit, News in Brief

UK-approved body capacity increases but not for IVDs

April 28, 2024
Important Notice

Extension of IVDR transition periods and early launch of Eudamed about to be finally adopted

April 26, 2024
News in Brief

Could the AI Act result in the limited availability of medical technologies?

April 21, 2024
News in Brief

Request for scientific opinion on brain stimulators without a medical purpose

April 16, 2024
News in Brief

EU Artificial Intelligence Act final text agreed to by Parliament Committees

April 14, 2024