MHRA moves to assuage medical device manufacturers over UK's post-Brexit plans
Published on 26th Oct 2022
Businesses will have more time to prepare for the new UKCA marking regime and comment on draft medical device regulations
Medical device manufacturers placing products on the market in Great Britain face a range of regulatory challenges, including the advent of the new UKCA marking regime (replacing CE marking), the lack of capacity among UK approved bodies to certify applicable medical devices and uncertainty over the future regulation of medical devices.
The Medicines and Healthcare products Regulatory Agency (MHRA) circulated a letter on 21 October 2022 that aims to address these concerns, stating:
- The "standstill period", during which medical devices placed on the market in Great Britain can bear CE marks, has been extended from July 2023 to July 2024.
- The government will publish drafts of the UK's new post-Brexit medical device regulations at least 60 days before they are laid before Parliament. This will allow for stakeholders to review and comment on the draft legislation before it comes into force in July 2024.
- The MHRA acknowledges industry worries over a lack of capacity concerning the UK's four approved bodies to fulfil their regulatory functions. To address this capacity shortage, the MHRA states that it is working with a further six organisations that have applied to become approved bodies, as well as other organisations that have expressed an interest in applying for the role.
These developments have yet to be confirmed on the MHRA website.
Medical devices placed on the market in Northern Ireland remain subject to EU regulations, and CE marking requirements, under the Northern Ireland Protocol, which enables free movement of goods between Northern Ireland and the EU.
Osborne Clarke comment
Some businesses may welcome the delay over the implementation of a standalone regime for Great Britain; particularly as it is likely that manufacturers will have the option to take advantage of transitional arrangements meaning that products with CE certification will be able to be placed on the market well beyond 2024. Others may be frustrated by the relatively slow pace at which the UK government is moving to provide certainty over the future regulation of medical devices. As we have reported, the MHRA consulted over the future regulation of medical devices last year and the UK government had stated that it expected to bring in new regulations in 2023. Now it appears that draft legislation will be published at some future date before it comes into force in 2024.
Nevertheless, manufacturers of medical devices can broadly welcome the MHRA's letter. Businesses will now have more time to prepare for the UKCA marking regime, industry will have the opportunity to comment on draft new medical device regulations and issues over the capacity of approved bodies are being addressed.
Taking a step back, it is possible that the delayed timetable for new regulations will affect the extent to which Great Britain diverges from the EU model. A significant section of the life sciences industry has been consistent in arguing that Great Britain should cleave to the EU regime, on the basis that following the EU model makes trade with the EU easier. These voices may become more influential if the current economic downturn persists and could result in the new regulations for Great Britain looking very similar to the EU model under the EU Medical Devices Regulation 2017.