MHRA opens call for evidence on prioritisation of designated standards for medical devices

The Medicines and Healthcare products Regulatory Agency (MHRA) has opened a call for evidence on how it should prioritise the designation of standards for medical devices in Great Britain, to inform future work under the Medical Devices Regulations (MDR) 2002.

Scope of the call

The exercise focuses on device standards used for medical devices placed on the Great Britain market. It invites views on the current list of designated standards and asks stakeholders to identify further standards that could be considered for future designation.

The MHRA states: “Designated standards are specific standards that have been officially recognised by regulatory authorities in the UK as providing a presumption of conformity with the essential requirements of relevant regulations.

“When a device complies with a designated standard, the device meets relevant essential requirements the standard addresses.”

What the consultation asks

The questionnaire requests factual information on how organisations use device standards in practice, and invites detailed suggestions about the content of the designated list.

Examples include:

• Whether already-designated standards are used to support compliance with MDR 2002, and which of those are used most frequently or are considered most important.
• Whether additional, non-designated standards should be added to the designated list, with fields to specify the standard and provide supporting detail.
• Whether any standards should be removed from the current designated list.
• Whether standards should be replaced with alternatives or updated where newer editions exist.

The survey also asks respondents to rate the practical value of designated standards for market access; for example, whether using designated standards provides time savings in submission and approval processes, and whether mappings to essential requirements are useful.

Context within ongoing reforms

This activity forms part of the MHRA’s wider programme to develop the future regulatory framework for medical devices in Great Britain, aiming to prioritise patient and public safety, maintain access to needed technologies, and support innovation. Input gathered through this exercise will inform how the agency prioritises future work on designation.

Relevance for BHTA members

For organisations engaged in standards and regulatory compliance, the consultation focuses on which medical device standards are relied upon to demonstrate conformity, and where changes to the designated list could improve alignment with current practice. Designated standards remain a recognised route to demonstrating compliance with essential requirements in Great Britain.

The deadline for responses to the MHRA’s open consultation is 30 September 2025. Respond online here.