This survey is designed so you can skip questions and/or opt to answer only certain sections. You do not need to complete your response in one sitting. To resume the survey, click the same link and you will be able to come back to it at another time to finish it off.
Once you have completed the survey, please submit your response by 11:59pm on Monday 15 September 2025.
Participants would benefit from having to hand information about medical devices manufactured and used under the Health Institution Exemption (HIE) (if any) within their organisation, such as:
- types of devices being manufactured under the HIE, and in which departments?
- information on the scale of use (e.g., does your organisation use the HIE to manufacture devices on an individual / small scale basis, or for larger volumes)?
- information on why your organisation uses the HIE (e.g., is it because patient needs are not met by commercially available devices etc)?
- information on how you monitor safety and performance of devices produced or modified under the HIE
- information on what guidance you are using in this area (e.g. does your organisation currently use MHRA guidance, or other sources)?
If you are responding on behalf of a health institution with more than one department, we encourage responses on behalf of the institution as a whole, as well as responses from specific departments, where possible. Please note we have included a definition of industrial scale in this survey which will be being kept under review.
Please note, this survey has been designed to show or hide certain sections and/or questions depending on your answers to previous questions.
