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NEWS

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
Brexit, News in Brief

UK MHRA gives CE marked devices new transition deadlines

July 4, 2023
Important Notice

EU AI Act approved by Parliament

July 3, 2023
News in Brief

Team-NB position papers on MDR and IVDR technical documentation

June 7, 2023
News in Brief

MDCG 2020-3 updated

June 5, 2023
News in Brief

Swiss Federal Council to mirror extended transition timelines for MDR legacy devices

June 2, 2023
News in Brief

Spain brings in additional national requirements

May 27, 2023
Brexit, News in Brief

UK updated guidance will reflect EU extensions

May 15, 2023