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NEWS

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
News in Brief

EU rules for device software working with hardware

November 29, 2023
News in Brief

European Commission publications update

November 15, 2023
Important Notice

EU medical device industry faces further delays related to EUDAMED

November 7, 2023
News in Brief

Is a centralised governance agency for medical devices feasible?

November 1, 2023
News in Brief

European Commission publishes third revision of the borderline manual

October 10, 2023
Important Notice

Advice on how to satisfy EU requirements for MDR legacy devices

October 6, 2023
Important Notice

Update on Regulation (EU) 2023/607 – extended MDR transition period

September 12, 2023
News in Brief

The European Commission’s AI Act now in final negotiation phase

August 24, 2023
Brexit

Great Britain’s plan to accept medical devices registered abroad

August 22, 2023
News in Brief

Harmonization of MDR and IVDR standards still slow

August 14, 2023
Important Notice

A closer look at MDCG 2023-3 on vigilance

August 11, 2023
News in Brief

Cybersecurity expertise shortage in EU

August 7, 2023
COVID-19, News in Brief

COVID-19 tests and their risk classification

August 2, 2023