Medical Devices Regulation Delay (Britain)

On 26 June 2022, the MHRA published the government response to the public consultation it had held on the future regulation of medical devices in the UK.

In a decision published 25 October 2022, the UK government has stated it will introduce a 12 month extension to the implementation of the future Medical Device Regulations, with the aim to bring the new regulations into force by July 2024.

The UK government has previously stated it intends to bring in new Medical Devices Regulations as a substantial reform of the current framework in Britain.

On the EU side, EU MDR (European Regulation 2017/745) came into force on 26 May 2021 after the UK had exited the EU. The EU MDR is significantly longer and more rigorous than the MDD (European Directive 93/42/EEC) it replaced. EU MDR does not apply in Britain. EU MDR does apply in Northern Ireland from 26 May 2021. Similarly, the related EU IVDR (in vitro Diagnostic Medical Device Regulations) has applied in Northern Ireland from 26 May 2022.

On the UK side, the current Medical Device Regulations 2002 (UK MDR 2002) which implemented the pre 31 Dec 2020 EU MDD, as amended by Brexit law following the UK’s exit from the EU, states that the acceptance of CE marked devices in Britain ends on 30 June 2023.

The UK government intends to introduce new legislation by Spring 2023. Manufacturers will be able to place CE marked devices on the British market after 1 July 2023. From July 2024, transitional arrangements will apply for CE and UKCA marked devices placed on the British market.

The current guidance “Regulating Medical Devices in the UK” which is listed in the Brexit Guidance List on Cardinal Environment Limited EHS Registers and Checklists will be updated.