Under the current EU membership, the UK is integrated into the EU medicines regulatory framework, including the European Medicines Agency, and all medical devices are subject to EU legislation, which uses CE marking to show compliance. The UK government has recently discussed the arrangements that will come into force regarding these regulations in the event of a “no deal” withdrawal of the UK from the EU on 29 March 2019. Fundamentally, the Medicines and Healthcare products Regulatory Agency (MHRA) would take on the functions currently undertaken by the EU for medicines on the UK market. This would require changes to UK law, via the 2012 Human Medicines Regulations (HMRs). The MHRA is planning a public consultation in “early autumn” on some of the key proposed legislative changes. Regarding medical devices, the UK will comply with all key elements of the Medical Devices Regulation (MDR) and the in vitro diagnostic Regulations (IVDR), which will apply in the EU from May 2020 and 2022 respectively. Furthermore, the UK will continue to recognise CE marking, although should this change in future, adequate time will be provided for businesses to implement any new requirements.

UK Department of Health and Social Care (2018). Guidance. How medicines, medical devices and clinical trials would be regulated if there’s no Brexit deal. Updated 14 September 2018. https://www.gov.uk/government/publications/how-medicines-medical-devices-and-clinical-trials-would-be-regulated-if-theres-no-brexit-deal/how-medicines-medical-devices-and-clinical-trials-would-be-regulated-if-theres-no-brexit-deal

 

The above items were taken from the October 2018 issue of Toxicology and Regulatory News which is sent automatically to members of bibra.

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