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NEWS

Important Notice

Registering a legacy device in Eudamed is a good step

May 12, 2023
News in Brief

Proposed general product safety regulation is expected to entry into force shortly

May 2, 2023
News in Brief

UDI helpdesk website published

April 13, 2023
Important Notice

Q&A document published on the extended transition period for medical devices under the MDR

April 11, 2023
Important Notice

MDR extended transition timelines and removal of MDR and IVDR sell-off period adopted

March 20, 2023
News in Brief

News on guidance documents

March 3, 2023
Brexit

UK MHRA’s new and higher charges for medical devices

March 1, 2023
Important Notice

European Commission proposal text accepted

March 1, 2023
Important Notice

EU guidance on Periodic Safety Update Reports

February 27, 2023
News in Brief

Templates on hand for sponsors of IVD performance studies

February 15, 2023
News in Brief

New EU approach on cancer screening

February 15, 2023
News in Brief

Guidance document on in-house devices

February 15, 2023
Important Notice

European Commission proposal for extended transition timelines published

January 12, 2023
IVDR, MDR, News in Brief

EU guidance on authorised representatives

January 11, 2023
News in Brief

EU notified bodies on harmonised standards regarding cybersecurity

January 6, 2023
Brexit

Extra year for CE-marked devices to access UK market

January 6, 2023
Important Notice

European Commission proposed MDR deadlines extension for legacy devices

December 14, 2022
News in Brief

EU notified body technical documentation reviews

November 17, 2022
News in Brief

Cybersecurity in the EU

November 8, 2022
News in Brief

News on useful publications: MDCG borderline manual and bsi white paper on performance evaluations

October 13, 2022