Chris Whitehouse, a political consultant and expert on medical technology policy and regulation at Whitehouse Communications, chair of the Urology Trade Association, trustee of the Institute of Medical Ethics and a governor of the Anscombe Bioethics Centre, updates readers on the MHRA and post-Brexit regulation.
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Big Ben and The Palace of Westminster.
The summer holidays are upon us and whilst members of Parliament can take a rest from all things medtech for now, work continues behind the scenes on the UK’s new regulatory framework for medical devices. This article takes you through the latest on the MHRA, post-Brexit regulation and what we can expect from the next few months.
Readers will know that much of the regulation of medical devices in the UK derives from EU legislation, as set out in the Medical Devices Regulations 2002. Since the end of the Brexit transition period, there have been changes to the way medical devices are placed on the market in Great Britain. Through the passing of the landmark Medicines and Medical Devices Act 2021, the MHRA was given the power to design, consult upon and implement a new legislative framework for medical devices.
Development of this framework is underway following an extensive consultation that concluded last year. The MHRA has said that core elements of the new regime will be introduced from July 2025 – two years later than the government had hoped – reflecting the complexity of the task at hand.
Following the recent passing of a statutory instrument (SI), the acceptance of CE marked medical devices in Great Britain has also been extended until 30 June 2028 (for general medical devices compliant with the EU medical devices directive) and 30 June 2030 (general medical devices, including custom-made devices, compliant with the EU medical devices regulation), which will give manufacturers and importers the flexibility to use either the CE mark or UKCA mark for many more years.
This extension came through a recognition that some patients faced a cliff edge of losing access to products and that industry needed more time to prepare for the transition. Given this long extension, it will be interesting to witness the trend in manufacturers pursuing UKCA mark certification at additional cost over the next year. According to a recent debate, in the year ending March 2023 (prior to the announcement of the extension) an estimated 9% of new medical products registered with the MHRA with the UKCA marking, despite the acceptance of the CE mark.
Close consultation with the medical devices industry has been integral thus far and will continue to be so. Having recently kickstarted their much-delayed industry focus groups, the MHRA are now consulting on post-market surveillance requirements which will set out how problems with devices will be identified and acted upon to protect public health. The legislation that will bring into force these requirements is expected later this year.
Be under no illusion that the MHRA is just a regulator, though. Emboldened by the freedoms afforded by Brexit, the Government is seeking to strengthen the agency’s powers and place it at the forefront of promoting patient safety and facilitating access to cutting-edge innovation. Indeed, these elements form two of the five pillars that the new regulatory regime will be built on, as per the Government’s announcement.
Whether this ambition can be realised will depend largely on two factors: capacity and funding. To transition to the UKCA mark, many manufacturers will have to undergo a conformity assessment by an approved body. But, there are concerns that these bodies do not have the capacity to deal with the sheer number of products that will require certification. The MHRA has assured industry that they are working to improve capacity but until the draft regulations are published, it will be difficult to assess the extent to which these bodies are prepared.
The Spring Budget allocated funding of £10 million to the MHRA over the next two years to help expedite the approval of innovative medical technologies developed in the UK, and to bring these to patients more quickly. The funding will also be used to support the establishment of an international recognition framework, which will see the MHRA partner with regulatory partners in other jurisdictions to bring in technologies already approved in countries such as the US and Japan.
The point of mutual recognition was a key discussion point during the House of Lords debate on the SI back in June. The former health secretary, Lord Lansley, argued that the greatest benefits to patients and public health would be the “progressive harmonisation” of regulation and mutual recognition of conformity assessments around the globe, but particularly within the EU.
The Government appears receptive to close regulatory alignment with the EU, and the first step to achieving this will be securing EU recognition of the UKCA mark as part of continued negotiations through the UK-EU Trade and Cooperation Agreement.
The MHRA is planning a further consultation on its future regime from October, and the conclusions drawn from this, as well as the focus groups, will hopefully give industry much needed clarity on the Government’s direction of travel.
Questions about or comments upon this article can be addressed to the author at chris.whitehouse@whitehousecomms.com.
