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In line with our roadmap deliverable, the Medicines and Healthcare products Regulatory Agency (MHRA) have been refining the current policy and guidance on the Health Institution Exemption (HIE) in Great Britain (GB) to align with the UK government’s missions, including the NHS England 10-Year Health plan, and the Life Sciences Sector Plan.
Stakeholder engagement has been central to this work. Feedback gathered through our recent call for evidence survey and stakeholder engagement sessions and health institution visits identified key areas for improvement, providing a clear, evidence-backed basis to inform guidance updates and future broader policy development. We are grateful to all stakeholders for their valuable contributions.
The MHRA has today published updated guidance on the health institution exemption. This will support hospitals and other health institutions when they manufacture new devices or modify existing devices to meet the specific clinical needs for their own patients.
The updated guidance offers clearer direction for health institutions on when and how the HIE can be applied in practise and includes scenario-based examples to illustrate its practical use. It also introduces leading practice guidelines that health institutions should follow when using the HIE, based on five principles:
- maintaining an appropriate Quality Management System (QMS)
- ensuring device traceability
- keeping technical documentation
- meeting essential requirements
- conducting post-market surveillance
To support consistent application, the guidance simplifies key terms including legal entity, health institution, manufacturing a medical device, adaptable devices, transfer of devices and custom-made devices. The updated guidance applies to general medical devices only and does not extend to in vitro diagnostic devices (IVDs).
Thank you,
The Medicines and Healthcare products Regulatory Agency
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