The Medicines and Healthcare products Regulatory Agency (MHRA) has launched a consultation on its proposals to extend existing transitional arrangements and continue to recognise medical devices approved in the EU “indefinitely”.
The proposals put forward look to support the extension of measures put in place in 2023 to recognise CE marked medical devices on the British market to 2030, in a move the MHRA states is aimed at protecting patient access and ensuring continued supply of “safe and effective” medical technologies.
“Around 90 percent of medical devices currently used in Great Britain are CE marked, and the proposals for indefinite recognition would ensure consistent long-term supply to support the health system,” the MHRA reports.
Feedback is sought on three proposals: the proposal to extend transitional arrangements for devices certified under the EU Medical Device Directive (MDD); to continue to recognise EU MDR and EU IVDR compliant devices; and to introduce an international reliance route for higher risk CE marked devices.
Interested parties are encouraged to respond online to the consultation, either agreeing in whole or in part with each of the proposals made by the agency, or recording their disagreement and concerns about the measures suggested.
“The number one request that the med tech industry made of us was to provide long term certainty over CE recognition,” MHRA chief executive Lawrence Tallon commented. “It is in the best of interests of British patients to ensure continued access to the latest medical devices approved in Europe. It is also in the best interests of the med tech sector to reduce friction and costs of doing business.
“In addition, we will re-position UKCA as a specialist route for first-in-market innovative products, including AI as a medical device,” Tallon continued. “This will be informed by the findings of the National Commission into the Regulation of AI in Healthcare which will report this summer.”
Wider trend: The MHRA on medical devices and emerging technologies
The MHRA recently opened an offering to provide regulatory advice meetings on medical devices and in vitro diagnostic devices for manufacturers, at a cost of £987 for one hour. During the one hour meeting, the person or organisation requesting support is to begin with a short presentation outlining their questions and the “issues and controversies” surrounding them. The service aims to provide regulatory advice relating to medical devices, particularly if the application of existing regulatory guidance is not straightforward.
The agency issued a call for evidence on the regulation of AI in healthcare, asking members of the public, clinicians, industry, and healthcare providers to share their views on the modernisation of AI rules, keeping patients safe as AI evolves, and the distribution of responsibilities between regulators, companies, healthcare organisations, and individuals. Insights from respondents will be heard by the National Commission into the Regulation of AI in Healthcare, established to consider what the regulatory rules should be around AI as a medical device. The Commission and its four working groups include health professionals, regulators, AI specialists, and experts from across the UK.
New guidance was also issued for the public and healthcare professionals on the use of apps and digital tools for mental health support, aiming to help people make more informed choices and “know what to do if something doesn’t feel right”. As part of the new guidance, the agency has published online resources including animations and real-world examples demonstrating “what safe, well-evidenced digital mental health technologies look like in practice”, going on to explain how to report concerns through the MHRA Yellow Card scheme. The resources form part of a project designed to support the safe and effective use of digital mental health technologies, funded by the Wellcome Trust.
