Health Institution Exemption – Stakeholder survey
Source: gov.uk (2025-11-21)

The MHRA invites health institutions in Great Britain to share their experience of the health institution exemption (sometimes referred to as an in-house manufacturing exemption).

The Government’s 10-Year Health Plan for England and the Life Sciences Sector Plan together set a trajectory toward embedding innovative technology in care and delivering it closer to where people live. Health institutions, at the forefront of care, are central to making this happen.

We aim to refine the health institution exemption policy within the medical devices regulatory framework that helps health institutions deliver safe, effective, and innovative devices to patients - closer to home.

Building on the government’s response to the 2021 consultation on the future regulation of medical devices in the United Kingdom (https://assets.publishing.service.gov.uk/media/62b577f6d3bf7f0b00165a32/Government_response_to_consultation_on_the_future_regulation_of_medical_devices_in_the_United_Kingdom.pdf), and to support delivery of the Medical Devices Regulatory Reform roadmap (https://assets.publishing.service.gov.uk/media/6759a8827e419d6e07ce2b21/Med_Tech_Regulatory_Roadmap_V2_December_2024.pdf) deliverable of refining policy and guidance on HIE to align with government strategy, the MHRA have been refining our policy on the health institution exemption, with an intent to develop updated guidance.

There are promising opportunities for this policy to evolve, such as enhancing access to innovative medical technologies closer to home, while ensuring robust safeguards for patients and public health initiatives. These include:
- Extending access – enabling exempted devices to be used beyond health institutions, supporting care delivery deeper into communities and within people’s homes.
- Strengthening safety – promoting enhanced post-market surveillance, governance and improving visibility of exempted devices to ensure continued safety and effectiveness.
- Delivering against reform shifts – enabling health institutions to reform the way our health services deliver care with hospital to community, analogue to digital and sickness to prevention.
We recognise the need for clear confines on when the exemption can be applied.

We’ve been speaking with and visiting health institutions and networks across Great Britain, gaining first-hand insights into how the current exemption is operating in practice, and the remarkable work being undertaken to help patients access innovative medical devices needed.

To shape the policy further, we will continue to gather insights from health institutions across Great Britain. Your inputs will inform our understanding of current practice, and better shape subsequent consultations, guidance, or regulatory updates we plan in the coming year.

Your input

We invite health institutions across Great Britain to complete a short survey of your experiences of the health institution exemption.

Please complete the questionnaire by 11:59pm Monday 15 September 2025.

For any questions relating to the completion of the survey, please email xxx@xxx.xx (mailto:xxx@xxx.xx), with “Health Institution Exemption Survey” in the subject line.

You may download the survey questions below for reference, before responding to this survey.

Please note, this survey has been designed to show or hide certain sections and/or questions depending on your answers to previous questions.