Early insights from MHRA’s stakeholder survey on the UK medical device regulatory framework

Last Updated on 13/10/2025 by Sarah Sarsby

Background

The Medicines and Healthcare products Regulatory Agency (MHRA), working with the Department of Health and Social Care, ran a call for evidence to inform its statutory review of the UK medical device regulatory framework.

The consultation received 123 responses from industry, trade associations, healthcare professionals, patient groups, and charities. To learn more about the consultation and see the BHTA’s full response, read this article.

As part of this work, MHRA held a workshop with trade associations, including the BHTA, to share early analysis from the responses and invite further input from stakeholders.

Survey results

The figures below summarise the initial responses from stakeholders to the MHRA consultation.

When asked – How well do you think the current UK medical device regulatory framework protects public health? – most felt it offers protection to some degree, with 40 percent selecting ‘somewhat effectively’ and 35 percent ‘effectively’. A further 12 percent said ‘very effectively’. Five percent answered ‘ineffectively’, and seven percent were ‘not sure’.

To the question – On a scale where 1 = not at all effective and 10 = extremely effective, how effective are the regulations in practice? – scores clustered in the mid‑to‑high single digits, with the largest share around six to seven, and relatively few at the extremes. This indicates a broadly moderate view of day‑to‑day effectiveness.

See the slide below for views on unnecessary or excessive regulatory burdens and whether stakeholders have encountered any issues, blockers, or areas of ambiguity when using the regulations.

To the question – On a scale where 1 = not at all clear, well‑structured, or easy to navigate, and 10 = extremely clear, well‑structured, and easy to navigate, how would you rate the framework? – responses typically centred around six, with relatively few at the extremes.

When asked “Are there any overlapping, duplicative, or outdated provisions in the framework?”, 47 percent said ‘yes’, 42 percent ‘no’, and nine percent were ‘not sure’.

Views were cautious when asked: “Do the regulations provide the appropriate balance of flexibility to respond to new technologies or emerging public health issues, and robust regulatory oversight?” 42 percent disagreed and 11 percent strongly disagreed; 27 percent neither agreed nor disagreed; 17 percent agreed; and two percent strongly agreed.

Responses to the question – Do you think the current balance between what is set out in legislation and what is provided in supporting guidance appropriate? – received mixed responses. 19 percent answered ‘yes’. 28 percent felt too much sits in legislation, 21 percent felt too much sits in guidance, and 42 percent were unsure.

See the slide below for stakeholders’ views on streamlining medical device legislation.

BHTA’s contribution

On behalf of member companies, the BHTA welcomed MHRA’s engagement and added two pragmatic suggestions in the session:

• Increased funding/resource allocation for “human at the end of the phone” resources to deal with industry queries that fall between MHRA’s guidance webpages (existing) and paid-for consulting services of MHRA (future, envisioned as part of MHRA’s enhanced functionality once the changes to regulations are out of the way); 
• Face-to-face sessions to discuss complex issues, e.g. how – in MHRA’s envisioned International Reliance routes – MHRA will divide labour between itself (as the regulator) and UK approved bodies & EU notified bodies when it comes to approvals, application processes, and technical file examination. 

Next steps

According to discussions with MHRA, there will be further stakeholder workshops in October.

Findings from the survey and these workshops will inform the review, with a report expected early next year; all feedback will be anonymised in the final report.