UK Update: Start of the New Year and MHRA Announces Road Map

By Karen Hill and Evangeline Loh

The medical device regulator for the UK, the Medicines and Healthcare Products Regulatory Agency (MHRA) has posted the 2024-2025 UK regulatory roadmap to illustrate its plans for the year.

MHRA targets for 2024

The MHRA released a press announcement (January 9, 2024) about the roadmap. The new framework is heralded as enabling a future to continue to protect patient safety, prevent shortage of medical devices and enhance the UK’s position as a “world-leading environment for medical technology innovators.”

The expectation is for priority measures protecting patient safety to be put in place in 2024 and the fundamental aspects of the new regulatory regime by 2025. Statutory Instruments (SI) will continue to be the legislative mechanism.

Quotes attributed to the head of the MHRA and representatives from medical device associations highlighted the international recognition the MHRA has received regarding its continuing role in the International Medical Device Regulators Forum (IMDRF) and the Global Medical Technology Alliance.

MHRA roadmap: SaMD, artificial intelligence and more

The transitional elements of the framework and the draft post-market surveillance (PMS) SI still exist. The roadmap consists of three pages: cover, accomplishments 2021-2023 and plans for 2024-2025.

Page two summarizes what has been achieved in the past two years, presented as a timeline. The timeline acknowledges the public consultation and stakeholder involvement. The work from the Software as a Medical Device (SaMD) and Artificial Intelligence (AI) roadmap are also emphasized in three SaMD guidance documents: crafting an intended purpose, reporting adverse incidents and predetermined change control plans for developers. For the future core framework, thus far, stakeholders have only discussed international recognition.    

MHRA plans for 2024-2025

The MHRA plans for the next two years are also presented as a timeline. Ongoing stakeholder discussions are expected to discuss elements of the new framework, culminating in the SI to be released in 2025.

Three more SaMD guidances are expected: good machine learning practice for medical device development mapping, AI as a medical device development and deployment best practice and data-drive SaMD research, development and governance. In addition, the AI Airlock Sandbox will launch.

We expect an IVD roadmap in 2024, as well as finalization of the PMS SI and accompanying PMS guidance.

Concluding remarks

The MHRA expects the new framework to be in place by 2025. Emergo by UL will continue to monitor and report on medical device regulatory developments in the UK.