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NEWS

News in Brief

TEAM-NB position paper on IVDR transfer agreement for surveillance

September 26, 2024
Important Notice

MDR extended transition period and notified body agreement

September 26, 2024
Important Notice

Efficient support for medical device manufacturers: mdi Europa and the EUDAMED database

September 22, 2024
News in Brief

EU launches call for regulatory medical technology innovation sandbox

September 12, 2024
Important Notice

The medical technology sector faces significant changes due to the EU’s upcoming PFAS restriction

September 9, 2024
News in Brief

First global open-access information database on medical devices

August 28, 2024
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