Hospitals and health institutions are now navigating a significantly refined regulatory landscape following the release of updated guidance for creating or modifying medical devices in-house to address specific, unmet patient needs. Effective December 17, 2025, this new framework from the Medicines and Healthcare products Regulatory Agency (MHRA) clarifies the use of the Health Institution Exemption (HIE), empowering healthcare professionals across England, Wales, and Scotland to develop bespoke solutions when suitable commercial alternatives are unavailable. This change is designed to foster innovation directly at the point of care, enabling the development of everything from specialized software for precise drug dosing in oncology to custom-built communication aids for patients with severe impairments, thereby bridging critical gaps in patient treatment and improving outcomes. The guidance aligns with broader national strategies, including the 10 Year Health Plan for England and the Life Sciences Sector Plan, underscoring a commitment to leveraging internal expertise for patient-centric advancements.
A New Framework for Innovation and Safety
The updated guidance introduces five core principles that health institutions must adhere to when utilizing the Health Institution Exemption, establishing a robust system that balances innovation with stringent patient safety protocols. Central to this framework is the mandate for institutions to maintain a comprehensive quality management system, ensuring that every stage of the device’s lifecycle—from conception and design to manufacturing and deployment—is governed by standardized, high-quality processes. Furthermore, the principles demand complete device traceability, allowing every component and material to be tracked from its source to the end user. Institutions must also demonstrate that their devices meet all essential safety and performance requirements, which involves rigorous testing and validation. The maintenance of detailed technical documentation is another critical pillar, providing a clear and auditable record of the device’s design, function, and manufacturing process. Lastly, the guidance requires ongoing post-market surveillance to continuously monitor device performance and patient outcomes, ensuring that any potential issues are identified and addressed swiftly and effectively.
To ensure consistent and clear application, the MHRA’s guidance provides practical clarity on its scope and implementation, offering everyday scenarios to assist professionals like medical physicists and clinical engineers in their daily work. A significant clarification involves the precise definition of a “health institution,” a term now explicitly defined to include hospitals and other clinical care facilities while excluding entities such as gyms, spas, and fitness centers. The document also addresses complex operational arrangements, such as when a third-party manufacturer is contracted to produce a device on behalf of a health institution, outlining the responsibilities of each party. A key prerequisite for using the exemption is that institutions must first verify that no suitable, commercially available product exists to meet the specific clinical need. If they proceed with in-house development, they must inform patients that their device was created under this exemption. It is crucial to note that this updated guidance applies only to general medical devices and does not cover in vitro diagnostic devices (IVDs).
Ensuring Patient Protection and Accountability
A cornerstone of the revised regulatory approach is the reinforced system for reporting and addressing safety concerns, which is essential for maintaining public trust and patient well-being. The guidance unequivocally states that all safety concerns or adverse incidents related to devices manufactured under the Health Institution Exemption must be reported through the MHRA Yellow Card scheme. This centralized reporting mechanism is the UK’s established system for collecting information on suspected adverse drug reactions and medical device incidents, ensuring that any issues are formally logged, investigated, and analyzed by the regulatory authority. By integrating in-house devices into this national surveillance system, the MHRA can identify emerging trends, assess risks, and, if necessary, issue safety alerts to the wider healthcare community. This requirement fosters a culture of transparency and accountability within health institutions, reminding them that while the HIE provides flexibility for innovation, it does not diminish their fundamental responsibility to prioritize patient safety above all else. This process has been made more accessible with simplified definitions of key terms to ensure uniform understanding and application across all institutions.
The Path Forward for Bespoke Medical Solutions
The implementation of this refined guidance marks a pivotal moment for healthcare innovation within the UK, establishing a clear and structured pathway for developing patient-specific medical devices. Health institutions must now review their internal processes to align with the five core principles, focusing on strengthening their quality management systems and documentation practices. The clarification on the scope of the Health Institution Exemption and the explicit reporting requirements through the Yellow Card scheme provide a dual framework of empowerment and accountability. This ensures that while clinicians and engineers are encouraged to create novel solutions for unique clinical challenges, patient safety remains the paramount concern. The practical scenarios included in the guidance will be instrumental in helping professionals navigate the regulations, ultimately fostering a more responsible and effective environment for in-house device development that enhances patient care.
