The UK Medicines and Healthcare products Regulatory Agency (MHRA) has unveiled its roadmap for 2024, outlining plans for future medical device and in vitro diagnostic (IVD) regulations. The agency aims to implement 11 core regulations, including the introduction of implant cards for patient device tracking, unique device identifiers (UDI) for easier product tracking, and changes in the classification of certain devices to align with international standards. The roadmap emphasizes patient safety, international harmonization, and responsiveness to technological advances.
A key focus of the roadmap is the development of regulations for Software as a Medical Device (SaMD), artificial intelligence (AI), and machine learning (ML) products. MHRA plans to release three SaMD guidances during the year, covering machine learning practices, AI as a Medical Device (AIaMD) development and deployment best practices, and data driven SaMD research. Additionally, the agency will launch the AI-Airlock project, serving as a regulatory sandbox for AI developers to generate monitored data for their products.
The roadmap reflects on MHRA’s achievements in 2023, highlighting measures to allow certain medical devices to remain on the market during the European Union’s transition to new regulations. The acceptance of CE marked medical devices in Great Britain will be extended, aligning with the EU’s regulatory transition timeline. Medical devices compliant with the previous directives can stay on the market until specific deadlines, providing manufacturers with flexibility.
The legislation also permits self-declared CE marked Class I medical devices and certain other devices to remain on the market under transitional measures until 2030. MHRA plans to develop a roadmap for IVD regulations in the coming year. Furthermore, the agency intends to introduce legislation to implement postmarket surveillance (PMS) requirements, clarifying expectations for manufacturers to establish surveillance systems and report their findings to the agency. The overall goal is to ensure patient safety, international alignment, and adaptability to evolving technologies in the medical device and IVD sectors.