Open call for evidence

Designated standards prioritisation

Summary

The MHRA invite feedback on the use of designated standards for medical devices and in vitro diagnostic (IVD) devices to help shape future initiatives.

This call for evidence closes at

Call for evidence description

The Medicines and Healthcare products Regulatory Agency (MHRA) is working to deliver a future regulatory framework for medical devices that prioritises patient and public safety, gives patients access to the medical devices they need, and ensures the UK remains an attractive market for medical technology innovators. 

 In line with this objective, we are committed to enhancing patient safety and harmonisation by more closely aligning with international standards and best practices. The MHRA is seeking your input through this survey on the prioritisation for designation of important medical device standards that support compliance with the Medical Device Regulations 2002 (MDR 2002) (No.618 as amended).

Your feedback is crucial in helping shape our approach to designating standards, ensuring that they are practical, effective, and beneficial for all stakeholders involved.

Your input

We would value your views and experiences on the device standards which are relevant to you or your organisation.

The findings from the survey will inform our ongoing prioritisation process for device standards designated.

Please complete the questionnaire by 11:59pm Tuesday 30 September 2025.

For any questions relating to completion of the survey, please email info@MHRA.gov.uk, with “Designated Standards Survey” in the subject line.

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

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

Documents

MHRA Designated Standards Prioritisation Survey questions

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Ways to respond

Updates to this page

Published 5 September 2025

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