MHRA Update on the U.K. MedTech Roadmap

By Karen Hill

Background

In Jan. 2024, the U.K. medical device regulator, the MHRA, shared a roadmap detailing how it planned to implement future medical device regulations. In September 2024, Dr. Robert Reid, Deputy Director, MHRA, Innovative Device, provided attendees at the RAPS Convergence with an update on that roadmap.

On Nov. 1, Dr. Laura Squire, Chief Healthcare Quality and Access Officer, MHRA, published this blog providing a further update on the anticipated timelines associated with upcoming changes to the medical devices legislation for Great Britain (GB).

Update on AI Airlock

On Oct. 7, applications for taking part in the AI Airlock, a regulatory sandbox that uses real-world AI as a Medical Device (AIaMD) product, which will inform future policy and guidance on how AIaMDs will be regulated, were closed. There were nearly 40 applicants, and the MHRA identified around six to participate in the pilot scheme. We expect the draft of guidance on Digital Mental Health Technologies and AI Development and Deployment to be published by the end of March 2025.

Additional comments about post-market surveillance (PMS)

Following its publication on the World Trade Organization (WTO) website on July 26, 2023, the draft PMS statutory instrument (PMS SI) was laid before parliament on Oct. 21, 2024. As Emergo by UL has reported, this PMS SI introduces new PMS requirements and gives manufacturers greater clarity on the surveillance, vigilance and reporting requirements for devices on the U.K. market to support continued safety and performance expectations. The new PMS rules will come into force following a 6-month implementation period after it is finally signed by the Minister following the requisite parliamentary debates, which is currently anticipated to be in the summer of 2025.

Further developments in international recognition

First introduced in May, a 6-week consultation is now planned to start in mid-November to gather views on plans for abridged approvals for certain medical devices already approved by the U.S. FDA, Health Canada, TGA Australia and in Europe. These provisions would be part of an SI which is planned to be laid before parliament in 2025.

Future core legislation is the Pre-Market SI

Now referred to as the Pre-Market SI, the early draft of the legal text is expected to be shared by the end of 2024 through trusted advisor groups. In addition to the above-mentioned international recognition plans, it will also contain measures to improve patient safety and the traceability of medical devices, such as Unique Device Identifiers (UDI) and Implant Cards for patients. The aim is to publish the full text on the WTO website by Spring 2025.

In vitro diagnostic medical device (IVD) roadmap

A draft of the long-awaited IVD Roadmap is in place and its publication is anticipated for the spring of 2025.

Expected transition timelines

In order to provide manufacturers with some assurance, the current transition timelines are outlined below:

• For devices that are UKCA marked before the new Pre-Market SI comes into force, medical devices, systems and procedure packs, and single-use combination products will have a three-year transition period after the new regulations take effect or until the current UKCA marking certificate expires, whichever is sooner.
   
• For IVDs that require Approved Body certification under the U.K. MDR 2002 (i.e., self-test, List A & B), a transition period of five years after the new regulations take effect, or until the current UKCA marking certificate expires, whichever comes sooner, will apply.
   
• For IVDs that do not require the involvement of an Approved Body, self-declarations would cease to be effective by the end of the five-year transition period from when the new regulations take effect.
   
• The rules for CE-marked devices remain unchanged. The transition periods for legacy devices, depending on classification, stop at the end of 2027 or June 30, 2028, and continue until the end of 2030 if they are compliant with the regulation.

Concluding remarks

While it is valuable to learn that progress is being made in revising the U.K. medical device legislation, it should be noted that although the revised roadmap is projected to be published before the end of the year, it is still in development. With many of the required procedural steps out of the MHRA’s control, the dates discussed above are only indicative at this time and subject to change.