The Medicines and Healthcare Products Regulatory Agency (MHRA), the medical device regulator in the UK, has unveiled its regulatory roadmap for 2024-2025. This roadmap outlines the agency’s plans to safeguard patient safety, prevent medical device shortages, and solidify the UK’s status as a global hub for medical technology innovation. The MHRA aims to implement priority measures for patient safety in 2024, with the complete framework of the new regulatory regime expected by 2025, utilizing Statutory Instruments (SI) as the legislative mechanism.
In a press release, the MHRA emphasized the international recognition it has received for its role in the International Medical Device Regulators Forum (IMDRF) and the Global Medical Technology Alliance. The roadmap covers various aspects, including transitional elements, draft post-market surveillance (PMS) SI, and three pages detailing accomplishments from 2021-2023 and plans for 2024-2025.
The achievements of the past two years are summarized in a timeline, highlighting public consultations and stakeholder involvement. Notably, the Software as a Medical Device (SaMD) and Artificial Intelligence (AI) roadmap resulted in three SaMD guidance documents focusing on intended purpose crafting, adverse incident reporting, and predetermined change control plans for developers. Discussions regarding the core framework have centered on international recognition.

MHRA’s Milestones and Future Plans: Advancing SaMD, AI, and Medical Device Regulation
Looking ahead to 2024-2025, ongoing stakeholder discussions will delve into the various elements of the new framework, with the SI slated for release in 2025. The MHRA plans to release three additional SaMD guidance documents covering good machine learning practices, AI development and deployment best practices, and data-driven SaMD research, development, and governance. Furthermore, the AI Airlock Sandbox is set to launch during this period.
Anticipated developments for 2024 include the release of an in-vitro diagnostic (IVD) roadmap and the finalization of the PMS SI along with accompanying guidance. The roadmap reflects the MHRA’s commitment to shaping a regulatory environment that fosters innovation, safeguards patient welfare, and ensures the continued growth of the UK’s medical technology sector.
Resource: Emergobyul, January 16, 2024