The Medicines and Healthcare products Regulatory Agency (MHRA) has published its latest MedRegs blog, Summer 2025, which includes new post-market surveillance regulations, outlines plans to consult later this year on indefinite recognition of CE-marked devices, and highlights ongoing development of early-access pathways for medical technologies.
This impacts infection control and safety protocols, and mentions ensuring rapid access to medical devices.
For the healthcare estates and facilities management industry, these developments within the medical devices sector are significant as they influence the standards, technologies, and compliance measures that shape modern clinical environments.
Rob Reid, Deputy director, Innovative Devices, said: “Last month was an incredibly important and exciting month for the UK healthcare system. July saw the publication of not one, but two pivotal policy documents.
“First, the 10 Year Health Plan for England set out the government’s plan to create a new model of care for the UK, one in which science and technology is central to supporting three radical shifts from hospital to community, analogue to digital and sickness to prevention. This was followed by the publication of the Life Sciences Sector Plan.
“Both plans set out the important role that the MHRA will play, committing to the development of agile, risk-proportionate pathways for the safe and rapid evaluation and approval of medical products.
“Streamlining our regulatory pathways will not only allow for faster patient access to new technology, but will also boost growth in the UK sector by reducing duplicative regulatory costs faced by manufacturers and focusing the domestic approvals route (UKCA) on first-in-market innovative technologies, including AI as a medical device.
“In direct response to consultation feedback, we have also announced that we will consult later this year on the indefinite recognition of CE marked products.
“Alongside the new routes to market, the Agency continues to develop tools to support discovery, development and access to innovation. The pilot Innovative Devices Access Pathway (IDAP) is currently under evaluation by its partners, including the Agency and the Department of Health and Social Care (DHSC). A key tool within the pilot was the Unmet Clinical Need Authorisation (UCNA). This tool enabled the MHRA to grant controlled patient access to innovative technology that meets an unmet clinical need, but has not been through a full conformity assessment.
“The important role that innovations in software and AI will play in the future of healthcare delivery are a major focus within government’s plans.
Artificial intelligence
“The MHRA’s AI Airlock is a great example of how the Agency can work with innovators, academics, and other regulators including with members of Health AI to support the development of safe innovation.
“As is clear from the publication of the 10 Year Health Plan, medical technologies will be increasingly important enablers of the UK’s future healthcare system.
“The regulatory framework that governs the routes to market and safe and effective use of these technologies is critical to the success of government plans.
“We will be laser focused on the rapid development and delivery of further components that prioritises safe and rapid access to the technologies that patients and the NHS need.”
