UK MHRA Gives CE-Marked Devices More Breathing Space In GB
Core Aspects Of Future Regime For Medical Devices To Apply From July 2025
Executive Summary
The long-awaited extension of the UK MHRA’s standstill period for CE-marked devices circulating on the Great Britain market was announced in late April, offering new transition deadlines that go beyond the one extra year promised by the agency in fall 2022. Industry is studying the implications.
You may also be interested in...
MHRA Includes UKCA Marking Updates In New IVD Guidance For Great Britain
The MHRA has issued an 18-page guidance on legislation governing the sale and supply of in vitro diagnostics in Great Britain and the main features of part IV (IVDs) of the UK MDR 2002 as amended.
MHRA Issues Guidance On Recognizing And Reporting Medtech Software Adverse Events
When it comes to medtech adverse events incidents may not always be obvious. This is especially the case with medical device software where indirect harm is the most likely outcome of an incident, the UK’s MHRA explains in new guidance.
Pivotal Opportunity For UK Medtech Must Not Be Wasted
The UK continues to work on its new medtech regulatory system and market access processes for innovations, but all the planning and preparations will count for little if not accompanied by sound execution, warns Lincoln Tsang of law firm Ropes & Gray.