Government guidance: regulation of medical devices post-Brexit

The UK government previously advised that the EU CE mark would continue to be recognised in the UK for a limited period of time, with a UK specific mark potentially being introduced in due course. Earlier this week, the UK government provided further clarity on these and other issues regarding the regulation of medical devices in the UK after 31 December 2020 which we have summarised below.

Most notably, the EU CE mark will continue to be used and recognised in the UK until 30 June 2023. Thereafter, any medical devices placed on the UK market will need to bear the UKCA (UK Conformity Assessment) mark. In the meantime, any CE marked device on the UK market will be viewed as UKCA compliant and any enforcement or market surveillance powers available to the Medicines and Healthcare products Regulatory Agency ("MHRA") in respect of the UKCA mark will also apply to CE marked devices.

New products being placed on the market after 01 January 2021 may obtain UKCA certification. If these same products are to be placed on the EU market, manufacturers will also need to obtain EU CE marking. Existing UK notified bodies with designations under the Medical Devices Directive 93/42/EEC, In Vitro Diagnostic Medical Devices Directive 98/79/EC or Active Implantable Medical Devices Directive 90/385/EEC will have their designations rolled over automatically, without having to undergo a new designation process, in order to assess products for a UKCA mark.

From 01 January 2021, whether CE marked or UKCA marked, all medical devices placed on the UK market will need to be registered with the MHRA. Class III devices, Class IIb implantable devices, and all active implantable medical devices will need to be registered within 4 months (i.e. until 30 April 2021). Other Class IIb and all Class IIa devices will need to be registered within 8 months (i.e. until 31 August 2021). Class I devices will need to be registered within 12 months (i.e. until 31 December 2021).

If you are a manufacturer based outside the UK and wish to place a device on the UK market, you will need to appoint a UK Responsible Person who will take responsibility for the product in the UK. The position with respect to responsible persons for products placed on the market in Northern Ireland differs.

Notably, the EU Medical Device Regulation and In Vitro Diagnostic Medical Devices Regulation will not automatically apply in the UK as retained law, because it will only take full effect on 26 May 2021, after the transition period has ended. However, the UK Medical Devices Regulations 2002 (which implement the EU Medical Device Directives) will continue to apply after 01 January 2021 "in the form in which they exist on 1 January 2021" e.g. as adjusted by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 which introduce a number of the requirements under the EU Medical Device Regulation and In Vitro Diagnostic Medical Devices Regulation in any event. Importantly, the guidance refers to the UK government looking to further strengthen medical device regulation via the pending Medicines and Medical Devices Bill. The  UK Government has stated "we have the opportunity to develop a robust, world-leading regulatory regime for medical devices that puts patient safety at the heart of the regulatory system. We will take into consideration international standards and global harmonisation in the development of our future system". This suggests that the UK Government may be looking to make changes to the regulation of medical devices in the UK sooner rather than later, which could in turn quickly lead to a disparity between the EU regulatory regime and the UK regulatory regime.  

*It should be noted that the position with respect to placing products on the market in Northern Ireland is different and more complex due to the Northern Ireland Protocol. We have not discussed this here for brevity.