Companies will have more time to prepare for the UKCA’s new labeling regime and comment on the draft medical device regulations
Manufacturers of medical devices bringing products to market in Britain face a range of regulatory challenges, including the advent of the new UKCA marking regime (replacing the CE marking), the lack of ability of UK Approved Bodies to certify applicable medical devices and the uncertainty of future medical device regulation.
The Medicines and Healthcare Products Regulatory Agency (MHRA) issued a letter on October 21, 2022 seeking to address these concerns, stating:
- The “standstill period”, during which medical devices placed on the market in Great Britain can carry the CE mark, has been extended from July 2023 to July 2024.
- The government will publish drafts of new UK medical device regulations post-Brexit at least 60 days before they are tabled in Parliament. This will allow stakeholders to review and comment on the bill before it comes into force in July 2024.
- The MHRA recognizes industry concerns about the lack of capacity of the UK’s four accredited bodies to carry out their regulatory functions. To address this capacity shortage, the MHRA says it is working with six other organizations that have applied to become Approved Bodies, as well as other organizations that have expressed an interest in applying for the role.
These developments are 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 allows the free movement of goods between Northern Ireland and the EU.
Commentary by Osborne Clarke
Some companies may welcome the delay in setting up a stand-alone regime for Britain; especially since it is likely that manufacturers will be able to take advantage of the transitional arrangements, which means that CE-certified products can be on the market well beyond 2024. Others may be frustrated by the relatively slow pace at which the UK government is preparing to provide certainty about future regulation of medical devices. As we reported, the MHRA consulted last year on future regulation of medical devices and the UK government had said it planned to introduce new regulations in 2023. It now looks like the bill will be released at a later date before its arrival. effective in 2024.
Nevertheless, medical device manufacturers can largely welcome the letter from the MHRA. Companies 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 questions about the capacity of approved bodies are being addressed.
Stepping back, it is possible that the delayed timing of new regulations will affect the extent to which Britain deviates from the EU model. A significant part of the life sciences industry has always argued that Britain should join the EU regime, on the grounds that following the EU model makes it easier to trade with the EU. These voices could become more influential if the current economic downturn persists and could cause new regulations for Britain to look much like the EU model under the 2017 EU Medical Devices Regulations.