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ABHI: June target for new UK MDR looking "ever more unrealistic"

Published by Alec Denniff, Medical Device Paralegal on

Peter Ellingworth – Chief Executive of the Association of British HealthTech Industries (ABHI) recently warned in a letter printed in the Financial Times that the June 2023 target date for the launch of the UK's new, fully operational Medical Devices Regulations is looking “ever more unrealistic”. Given that ABHI is the UK’s leading Trade Association for health technology, representing more than 330 companies in the UK, this letter should be ringing alarm bells.

Despite government proposals which seek to make the UK a more attractive market from a regulatory perspective following Brexit, there are signs that the political and economic turmoil in the UK is taking its toll. This has raised fears that post-Brexit opportunities are not going to be realised.

The MHRA undertook its Consultation on the Future Regulation of Medical Devices in the UK between September and November 2021, seeking views on basic issues such as the scope of the legislation, as well as more topical content such as software and artificial intelligence. It received 891 responses from a range of interested parties: health professionals, medical device manufactures, trade associations, healthcare institutions, and trade associations.

The MHRA published its own response on 26 June 2022. This broadly outlined its intention to align internationally in a number of areas, particularly with the International Medical Device Regulators Forum. However, it could certainly be said that the devil is in the detail, and no draft legislation has been published to date.

Ellingworth wrote to urge that the government take “urgent action on completing the necessary legislative processes” to give the industry clarity on the regulation of medical devices, IVDs and med-tech products. He notes that industry concerns are growing that the UK may end up with a rushed regulatory response, threatening to damage growth opportunities for the UK HealthTech sector.

This assessment is echoed by a recent ABHI membership survey, which found that, following the publication of the MHRA’s response in July, roughly 75% of the health technology industry believe that the UK will no longer be seen as a priority globally. 

Given that the new UK regulations have not yet even been published in draft form, there is a risk for manufacturers that we are already beyond the point in time at which they would need to take action in order to meet the June 2023 target date. This message was also emphasised at the ABHI’s regulatory conference last week by Graeme Tunbridge, former director of medical devices at the UK MHRA, and now Senior Vice President for Regulatory and Quality, Medical Devices at BSI. 

The ABHI survey data also suggests that the UK has fallen behind both the EU and the US as an attractive place to do business or to promote the development of innovation. Other speakers at the ABHI conference called for “decisive and rapid action” to prevent damage to the long-term future of the UK as a place to invest and innovate. 

Syntacog is monitoring developments in this area and will publish further updates as and when announcements are made. Our Regtik platform allows HealthTech companies to self-assess the classification of their medical device products and keeps them up-to-date on how each product is affected by regulatory change.