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NEWS

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
News in Brief

Availability swissdamed and new negotiations between the EU and Switzerland

April 5, 2024
Important Notice

European harmonised standards to be without charge

March 17, 2024
News in Brief

EU Data Act causes difficulties for medical device manufacturers

March 14, 2024
News in Brief

MDCG published guidance on EMDN code updates and clinical investigation plans

March 13, 2024
News in Brief

Potential applicability of Regulation (EU) 2023/1115

March 12, 2024
News in Brief

Revised product liability directive

March 9, 2024
Important Notice

Language requirements overview for the Union market

February 14, 2024
News in Brief

MDCG published device specific vigilance guidance

February 8, 2024
Important Notice

Extension of IVDR transition periods and early launch of Eudamed in the pipeline

February 7, 2024
Important Notice

EU’s first reference laboratories for high-risk Class D IVDs

January 14, 2024
News in Brief

Update to MDCG 2021-27 on importer and distributor roles

January 12, 2024
News in Brief

European Commission publications update on clinical investigations and annex XVI products

January 11, 2024
News in Brief

Manufacturers must act now to satisfy IVDR

December 4, 2023
News in Brief

AI significant in October regulatory discussions

December 1, 2023