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UK MHRA · UK · 4 Sep 2025 · Consultation

Designated standards prioritisation

AI-generated summary

The MHRA is seeking stakeholder input through a survey on prioritising medical device standards for designation under the Medical Device Regulations 2002. The survey aims to align UK standards with international best practices while supporting patient safety and market access. Responses must be submitted by 11:59pm on 30 September 2025. Survey findings will inform the MHRA's ongoing prioritisation process for designated standards.

From UK MHRA

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.

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.

Excerpt from the official page. The original is authoritative.