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NEWS

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
News in Brief

Implementing Decision (EU) 2025/1324 on Expert Panels for Orphan Devices

July 11, 2025
News in Brief

New CECP Scientific Opinion Published

July 10, 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
Brexit, Important Notice

MHRA Fee Increase

July 1, 2025
News in Brief

New Q&A Guidance: MDCG 2025-5 on IVDR Performance Studies

June 25, 2025
News in Brief

New MDCG Guidance Alert

June 25, 2025
Important Notice

MHRA celebrates PMS Regulation as the beginning of a new era in UK device framework revolution

June 24, 2025