Introduction
The Medicines and Healthcare products Regulatory Agency (MHRA) is working to refine its policy and guidance on the Health Institution Exemption (HIE). The policy exempts certain devices that are manufactured, used or modified by a health institution for use within that health institution from meeting the requirements of the Medical Devices Regulations 2002 (MDR 2002).
The MHRA is inviting stakeholders in Great Britain (GB) to share information on how the health institution exemption (also referred to as an in-house manufacturing exemption) is currently being used in practice. We welcome your responses.
Please note, this survey is open to health institutions in GB. It will remain open until 11:59pm on Monday 15 September 2025 and should take about 15 - 20 minutes to complete.
Findings from this survey will inform policy options for reviewing the current position on the health institution exemption in GB. The survey is not a formal public consultation, and any subsequent review of the HIE will be subject to applicable consultation requirements.
For any questions relating to the completion of the survey, please email info@MHRA.gov.uk, with “Health Institution Exemption Survey” in the subject line.