UK–EU medical devices regulation: alignment, divergence and transition—GB regime, NI under EU rules, PMS reforms, IVD/SaMD updates and international reliance routes

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Practice notes

This Practice Note functions as a reference point to contrast the principal provisions of the current UK framework for medical devices; the EU framework as set out in the Medical Devices Regulation (MDR), Regulation (EU) 2017/745, and the In Vitro Diagnostic Medical Device Regulation (IVDR), Regulation (EU) 2017/746, respectively; and the proposed UK reforms. On 25 November 2021, the Medicines and Healthcare Products Regulatory Agency (MHRA) closed its public consultation on proposed updates to UK medical device regulation (see: LNB News 16/09/2021 90). The government’s reply was published on 26 June 2022. It also confirmed an intention to advance the vast majority of proposals, which collectively underpin the comparisons in this Practice Note. See News Analysis: A closer look at MHRA’s proposals on future regulation of medical devices in the UK. Progress in laying the new regulations has now been delayed while the UK engages with industry and stakeholders on several elements (for example, see: MHRA extends implementation of future Medical Devices Regulations to July 2024-LNB News 26/10/2022 35, and MHRA publishes post-Brexit plans to reform medical devices regulation-LNB News 27/06/2022 48). The forthcoming rules will be introduced through four core SIs that will substantially revise the Medical Devices Regulations...

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Web page updated on 28/05/2026

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