News | mdi Europa

NEWS

News in Brief

EU AI Act: Parliament votes to delay high-risk rules

April 17, 2026
News in Brief

New harmonised standards for sterilizers and hearing aids listed under the MDR

April 12, 2026
News in Brief

New CECP opinion published: Expert panel backs extended indication for cardiac pacing lead

April 10, 2026
News in Brief

Navigating supply interruptions: European Commission publishes revised Q&A on article 10a obligations

April 3, 2026
News in Brief

Recording now available: Commission high level conference on MDR/IVDR revision

April 2, 2026
Important Notice

Updated MIR form v7.3.1: Mandatory from 1 May 2026

March 31, 2026
Important Notice

European Commission adopts two MDR amendments easing conformity assessment obligations

March 23, 2026
News in Brief

Action required: IVDR class C legacy device deadlines are approaching

March 15, 2026
News in Brief

Team-NB sets out expectations for combinatorial IVD medical device claims

March 11, 2026
News in Brief

EU regulatory overhaul sparks debate

March 8, 2026
Brexit

MHRA opens consultation on the future of CE marking in Great Britain

March 2, 2026
News in Brief

European Commission hosts conference on medical devices in March

February 5, 2026
News in Brief

New set of harmonized standards published

January 30, 2026
News in Brief

Meet mdi Europa at World Health Expo 2026

January 15, 2026
Important Notice

MDCG 2025-10 — Guidance on post-market surveillance – manufacturers should review PMS documents

January 2, 2026
News in Brief

MDCG 2025-9 — Guidance on breakthrough devices (BtX)

December 23, 2025
Important Notice

Draft implementing regulation — notified body practices

December 19, 2025
Important Notice

The EUDAMED first four modules will be mandatory to use as from 28 May 2026

December 17, 2025
Important Notice

EU MDR & IVDR reform: what manufacturers need to know

December 16, 2025
News in Brief

News from the European Commission

December 9, 2025