UK Medtechs Mull MHRA Roadmap, Approved Body Capacity And IVD Rules For NI

Medtechs see a workplan but no firm timings as UK moves towards new regulatory system

 
• By Ashley Yeo
  
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A limited increase in approved body capacity is announced by the UK Medicines and Healthcare products Regulatory Agency and Northern Ireland regulation gets Westminster’s attention.

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An expansion of UK capacity to audit under the UKCA marking system was announced by the Medicines and Healthcare products Regulatory Agency (MHRA) on 23 January. UL International’s scope of designation was extended further to medical devices. The company’s IVDs scope was extended a year ago. (Also see "February Announcements On UK’s Medtech Regulatory System Change Awaited" - Medtech Insight, 23 January, 2023.)

The list of UK approved bodies qualified to audit medical device technical files remains at seven overall, unchanged since three...

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