The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has announced sweeping reforms aimed at improving patient access to cutting-edge medical technologies and easing the regulatory burden on manufacturers.

In a move welcomed by industry stakeholders, the MHRA has published the UK government’s response to its public consultation on the future of medical device regulation in Great Britain (GB). The new framework is designed to modernise the market entry process, aligning it with international standards while promoting innovation, including technologies such as AI-powered medical devices.

A key part of the reform is the introduction of international reliance routes. These new pathways will allow for faster approval of medical devices already cleared by trusted regulators in countries like the United States, Canada, and Australia. This streamlining will help ensure British patients gain quicker access to safe, globally approved medical innovations.

The MHRA has also expressed plans to consult on indefinitely recognising CE-marked devices, reflecting feedback from stakeholders who called for greater regulatory coherence with European standards. In parallel, the agency will support removing the requirement for physical UKCA marks on devices and packaging, once unique device identification (UDI) systems are fully in place. This will improve traceability while eliminating unnecessary barriers to market entry.

These measures are in line with the UK’s Life Sciences Industrial Strategy, Sector Vision, and the 10-Year Health Plan for England, which aim to foster innovation and strengthen the UK’s global leadership in life sciences.

Health Secretary Wes Streeting highlighted that the new reforms would help deliver life-saving devices to NHS patients faster, free from unnecessary bureaucracy. Minister for Science Lord Patrick Vallance praised the shift, calling it a practical step towards faster, evidence-based approvals and better use of regulatory resources.

MHRA CEO Lawrence Tallon noted that the reforms would position the UK as a global hub for safe and effective medical device innovation. Meanwhile, Professor Tom Clutton-Brock hailed the changes as the most significant regulatory advance since the system's inception, striking the right balance between safety and innovation in a rapidly evolving MedTech landscape.