19 May 2026
The MHRA published a draft of its new regulation, now open for comment on the WTO website. Click here to read what’s changing with UKCA Marking, the new International Reliance framework, and the proposed transition times.
4 May 2026
Find here an overview of the April news not already reported: Team-NB new and updated guidance, Article 10a decision flow chart, update on new common specifications, and more.
3 April 2026
March EU, UK, and Swiss regulatory updates not already individually reported: MDR/IVDR reform progress, MIR Form 7.3.1 update, swissdamed manual entry delay, UK clinical investigation guidance, and more.
3 March 2026
The IMDRF published its annual update to the Adverse Event Report (AER) terms, terminology, and codes. Click here for the link, and an overview of the new, modified, and retired terms.
2 March 2026
Feb 2026 news not already reported: UK public database now shows brand/trade names, swissdamed M2M and manual registration launch, IMDRF AER Guidance, and more.
16 February 2026
MHRA proposes MDD transition extension to Dec 2028, indefinite CE marking recognition, and international reliance. Consultation closes April 10, 2026.
2 February 2026
Jan 2026 news not already reported: New EMDN codes with email notifications, WET list expansion in Q1 2026, swissdamed webinar, Swissmedic vigilance guidance, and more.
30 January 2026
New EU MDR (12) and IVDR (6) harmonized standards have been published, plus an updated 2026 UK designated standards list. Click here for the list and source links.
7 January 2026
December 2025 regulatory updates not previously already reported on: breakthrough device guidance MDCG 2025-9, draft NB legislation, UK MHRA changes, and swissdamed timelines.