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NEWS

News in Brief

News from the European Commission

December 9, 2025
News in Brief

Draft standard on clinical evaluation published

December 3, 2025
News in Brief

ISO 10993-1:2025 published

December 1, 2025
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Team-NB position paper — When companion-diagnostic changes require notified-body approval

November 21, 2025
News in Brief

Clinical evidence requirements under the IVDR — MedTech Europe eBook

October 8, 2025
Important Notice

MDCG Q&A — trend reporting

October 6, 2025
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Manual on Borderline and Classification under the MDR and IVDR updated

October 1, 2025
News in Brief

EN IEC 61326-2-6 was updated

September 28, 2025
Brexit, Important Notice

MHRA revises post-market surveillance fees for medical device companies

September 17, 2025
News in Brief

EU4Health supports orphan devices and SMEs

September 17, 2025
News in Brief

New Revision: MDCG 2024-14 Rev. 1 on Master UDI-DI for Contact Lenses

September 14, 2025
News in Brief

TEAM NB issued revision 2 of IVDR best practice document

September 10, 2025
News in Brief

EU launches consultation to develop guidelines and Code of Practice on transparent AI

September 5, 2025
Important Notice

Targeted revision: MDR & IVDR — Have your say

September 5, 2025
Important Notice

Updates for Switzerland – eIFU and device registration

August 31, 2025
News in Brief

AI Act provisions for general-purpose AI apply

August 14, 2025
News in Brief

European Commission publishes template for summary of training data

August 7, 2025
News in Brief

The European Commission published MDCG 2025-7 on the use of a Master UDI-DI for certain optical devices

August 3, 2025
News in Brief

EU pilot for all-in-one regulatory pathway for drug and diagnostic trials

July 23, 2025
News in Brief

General-Purpose AI Code of Practice published

July 15, 2025