The deadline for the full implementation of MDR17 was postponed for 1 year (until 26 May 2021) due to the general chaos caused by the COVID-19 pandemic.

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Draft UK medical devices regulations [Medical Devices (Amendment etc) (EU exit) Regulations 2019 ] were produced in the second half of 2019 but were subsequently withdrawn for reasons associated with the difficult Brexit negotiations with the EU. However, they were the direct result of a UK Government policy decision to closely align future UK medical device regulation with MDR 2017. 

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The whole "UK MDR issue" was further complicated by the EC's understandable decision to extend the transition period for MDR 2017 by 1 year, as explained above. However, the decision was made on 23 April 2020, only one month before all EU states should have been fully compliant anyway. The UK exited the EU on 31 January 2020 but preparations within NHS Medical Physics and Clinical Engineering departments to comply with MDR 2017 should have been underway since early 2016, when detailed guidance articles started to appear in Scope, the Journal of the Institute of Physics and Engineering in Medicine (IPEM). See Publications and References. For access to Scope, go to ipem.ac.uk.

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The UK MHRA conducted a consultation process on proposed new regulations in late 2021. The new UK Medical Device Regulations were planned to be issued by June 2023 but this has now been delayed until July 2025. Until then, Great Britain continues to be governed by the UK's 2002 Medical Device Regulations, which are based on the old EU Medical Device Directives. Note: Northern Ireland is subject to EU MDR17 under the special arrangements made following Brexit.

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Current MHRA guidance on all aspects of UK medical device regulation can be viewed here.

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This page last updated: 03 April 2024