UK Medical Device Regime Update – where do we stand three days into the new system?

Last Updated on 11/07/2025 by Samantha Lewis

At the BHTA 2025 Joint Section Meeting, William Lee, Head of Policy and Compliance at BHTA, gave an update on the UK Medical Device Regime.

The Year in Review: Laying the Groundwork

The past 12 months have seen intensive regulatory activity. A pivotal consultation that closed in January 2025 addressed critical areas such as international reliance, UKCA marketing, IVDs, and the integration of assimilated EU law. As part of BHTA’s standard process, members were actively engaged in shaping the association’s response.

April 2025 marked a significant shift when the Medicines and Healthcare products Regulatory Agency (MHRA) transitioned to full cost recovery, triggering a controversial overhaul of its fee structure. Thanks to robust advocacy by BHTA and other trade associations, key fee components were delayed, giving industry stakeholders more time to prepare.

On 16 June 2025, updated post-market surveillance requirements came into force, enhancing technical obligations for incident reporting through MHRA’s MORE database. While the changes are largely evolutionary, their implementation reflects the UK’s efforts to tailor regulatory processes post-Brexit.

Key Developments Since July 1st

As of early July, new medical device regulations are technically in place. However, practical implementation remains limited. For instance, the long-anticipated international recognition pathways have not yet been activated, though BHTA and other groups continue to press MHRA for progress.

Notably, a new Trusted Advisor Group, including BHTA, has been established to support transparent dialogue with MHRA. While details of its proceedings remain confidential, its formation signals a commitment to greater industry collaboration.

Looking Ahead: Anticipated Changes and Strategic Priorities

A statutory instrument concerning pre-market conditions is expected later this year, likely expanding on topics not fully addressed in the 2024 consultation. Additionally, MHRA will notify the World Trade Organisation about updates to device regulations as part of its post-Brexit obligations.

One key area of interest is the potential for perpetual extension of CE-marked product acceptance on the UK market beyond current 2028/2030 deadlines. BHTA supports this simplification and has communicated this stance to the new MHRA CEO.

MHRA is also exploring a groundbreaking programme on the remanufacture of Class I single-use devices in partnership with NHS Scotland and the Department of Health and Social Care. This initiative reflects growing interest in sustainability and circular economy principles within medtech.

Fee Structure Revisions and What Members Should Do Now

While MHRA’s new fee model came into effect in April, the most contentious aspect—per-product GMDN-based charges—has been waived for fiscal year 2025/26. However, from 2026/27 onwards, fees may be levied based on GMDN Level 2 categories, with possible discounts in the first year.

BHTA urges members to review their DORS registrations to ensure accuracy and respond promptly to MHRA communications. Proactive updates will be crucial as MHRA prepares to issue indicative fee forecasts based on registration data.

The Bigger Picture: NHS and Sector Trends

Bill Lee concluded with a broader perspective on NHS strategy. The focus is shifting towards community-based care, hospital-to-home models, and the central role of technology. The MedTech Directorate, led by David Lawson, is emerging as a central driver of future policy.

While value-based procurement remains a strategic goal, ongoing cost pressures could affect its rollout. NHS Supply Chain continues to prioritise lowest-cost procurement models, and there is no sign of a move toward centralised NHS purchasing pathways.

In summary, BHTA remains a vocal advocate for workable, transparent regulation and ethical market access. Through continued engagement with MHRA and other stakeholders, it seeks to ensure that members are well-informed, supported, and strategically positioned in this evolving regulatory landscape.