Pre market medical devices regulation – stakeholder impact survey
Call for evidence description
About this survey
The Medicines and Healthcare products Regulatory Agency (MHRA) is running a business and stakeholder impact survey on proposed changes to pre-market regulatory requirements for medical devices and in vitro diagnostic devices in Great Britain.
The proposals are set out in the draft Medical Devices (Amendment) Regulations 2026, which have been published on the World Trade Organization notification portal.
The draft Medical Devices (Amendment) Regulations 2026 bring forward patient-centred and proportionate regulatory requirements to prioritise patient safety and access to innovative medical technologies. These proposals build on earlier public consultation and engagement.
This survey seeks to gather evidence on the practical impacts of the proposed pre‑market changes, including likely costs, benefits, and implementation considerations.
Before completing the survey, we encourage respondents to read the accompanying guidance document, which provides further detail on the proposals.
Our request
We welcome views from a range of stakeholders, including:
- patients and patient representative organisations
- healthcare professionals and healthcare providers
- medical device manufacturers and suppliers
- trade bodies and other interested organisations
Please share views and experiences that are relevant to you or your organisation. Where possible, provide specific examples related to the impacts of the proposals.
Responses will inform the Impact Assessment and future implementation of the regulations. All responses will be analysed in aggregate and anonymised.
Survey deadline
The deadline for completing the questionnaire is 11:59pm (UK time) on Friday 19 June 2026.
If you have any questions about the survey, please contact futuredevicesregulations@mhra.gov.uk with “2026 Regulations” in the subject line.