Primary Legislation Powers for Direct Licensing
The UK Department of Health and Social Care (DHSC) published an official policy fact sheet on 9 September 2026 detailing proposed legislative amendments under the Health Bill concerning medicines and medical devices regulatory reforms.
The centerpiece of the device-related reforms is the creation of primary enabling powers allowing the Secretary of State to establish a dedicated medical device licensing regime through future secondary legislation. Under this proposed framework, the Medicines and Healthcare products Regulatory Agency (MHRA) would gain statutory authority to evaluate technical dossiers and grant market access licenses directly, creating an alternative or supplementary route alongside the existing third-party UK Approved Body conformity assessment system.
Addressing Market Access Bottlenecks and Global Information Sharing
The fact sheet details three foundational pillars designed to modernize Great Britain’s post-Brexit regulatory infrastructure:
- Alleviating Approved Body Capacity Constraints: Since the implementation of the UKCA framework, manufacturers have faced prolonged delays due to limited designated UK Approved Body capacity. A direct MHRA licensing channel aims to provide a reliable, government-administered route to market, mitigating systemic review backlogs for innovative and essential medical technologies.
- Enhanced International Safety and Vigilance Data Sharing: The Bill introduces explicit statutory gateways allowing the MHRA to exchange safety signals, medical device incident reports, and post-market surveillance data directly with trusted international regulatory partners (such as the US FDA, Australia’s TGA, and Health Canada) without requiring cumbersome ad-hoc data-sharing agreements.
- Dynamic Legislative Modernization: The measures will enable UK medical device statutory instruments to reference international consensus standards and technical specifications more fluidly, minimizing legislative lag as medical technology evolves.
Practical Implications and Strategic Horizon for Manufacturers
While the policy fact sheet marks a significant strategic pivot toward an agency-led approval model, its practical implications must be contextualized:
- Enabling Legislation Without Immediate Administrative Change: The fact sheet outlines enabling powers within primary legislation currently before the UK Parliament. Existing market access routes—including designated UK Approved Body audits and the recognized transition timelines for valid EU CE marks (extending to 2028 and 2030 depending on device classification)—remain in full effect.
- Upcoming Public Consultations on Implementation Details: Specific parameters governing which device classes or breakthrough designations will be eligible for direct MHRA review, applicable statutory fees, and filing formats will be formulated through subsequent secondary legislation and stakeholder consultations.
- Long-Term UK Access Strategy: Manufacturers experiencing certification delays in Europe or the UK should monitor MHRA pilot programs and secondary consultation timelines to evaluate direct UK licensing as a future regulatory pathway.
Sources
- Primary official sourceHealth Bill: medicines and medical devices regulatory reforms - fact sheet (opens in a new tab)Department of Health and Social Care