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 bodies were added in summer 2023. UL’s medical devices designation expires on 21 December 2028
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