News | mdi Europa

NEWS

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
News in Brief

Draft standard on clinical evaluation published

December 3, 2025
News in Brief

ISO 10993-1:2025 published

December 1, 2025
News in Brief

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
News in Brief

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