Category: News in Brief

Important information on MDR, IVDR, Guidance Documents, European Commission and other news related to CE Marking of Medical Devices.

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
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
News in Brief

MDCG published device specific vigilance guidance

February 8, 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
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
News in Brief

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

August 24, 2023
News in Brief

Harmonization of MDR and IVDR standards still slow

August 14, 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
CE Marking, IVDR, News in Brief

The IVDR is now fully applicable – but it means not the end of the world

June 8, 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
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
News in Brief

News on guidance documents

March 3, 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
IVDR, MDR, News in Brief

EU guidance on authorised representatives

January 11, 2023