The UK Medicines and Healthcare Products Regulatory Agency (MHRA) is the designated Competent Authority for medical device regulation and enforcement within the UK. It produces guidance on how to comply with medical device regulations.

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Following a public consultation (on all aspects of UK medical device regulation) in September 2021, it was expected that the MHRA would update its current guidance (issued January 2021) on the so-called MDR health institution exemption (HIE) during 2022, but this is still awaited. In the meantime, it has been agreed that the President of IPEM will officially contact the MHRA to seek clarification for MP and CE (MPACE) departments involved in the production of medical devices. It has also been agreed that IPEM's Engineering Policy & Standards Panel will work on further advice to members. 

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Many MPACE departments have already adopted effective quality management systems, either under ISO 9001 or ISO 13485, the latter being aligned with EU MDRs. IPEM has also worked with the British Standards Institute (BSI) in the development of BS70000, which is now an accreditation MPACE standard under UKAS. IPEM is also a member of the UKAS Technical Advisory Committee, which is working to ensure that in-house manufacture of medical devices is also covered within the MPACE quality management standard, in line with regulations.

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This page last updated: 03 April 2024