Tag: MDR

News in Brief

New EUDAMED version released

May 23, 2026
Important Notice

EUDAMED training 2026 – key opportunity for all medical device stakeholders

May 8, 2026
News in Brief

Switzerland–EU MRA: Momentum returns, but a long way to go

May 3, 2026
News in Brief

Update Alert from the European Commission – borderline products, EMDN codes, MIR status and clinical investigations/ performance studies

May 2, 2026
Download Section, Library

Complete Download Section mdi Europa

April 30, 2026
Important Notice

MDCG 2021-24 Rev.1, updated classification guidance published

April 29, 2026
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

European Commission adopts two MDR amendments easing conformity assessment obligations

March 23, 2026
News in Brief

EU regulatory overhaul sparks debate

March 8, 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
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

ISO 10993-1:2025 published

December 1, 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

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
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

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

August 3, 2025
Important Notice

Electronic Instructions for Use (eIFU) for Professional Use Medical Devices

July 9, 2025
Important Notice

MDCG published guidance 2025-6

July 8, 2025
Important Notice

Guidance on EU MDR/ IVDR and AI Act interplay

July 8, 2025
News in Brief

MDCG 2019-11 rev. 1 published by the European Commission

July 1, 2025