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.

To accelerate traceability of medical devices, NHS Supply Chain has launched a new policy on Data Standards for Supplier Product Coding.

The new policy means that medical devices and clinical consumables suppliers are to adopt globally recognised coding standards for product identification, preferably the GS1 Global Trade Item Number (GTIN).

NHS Supply Chain also requires medical devices to carry ‘Unique Device Identification’ (UDI) compliant barcode labels, which will carry scannable information relating to the production of the device, for example the expiry date and the serial or lot number.

There are two documents available to download on the NHS Supply Chain website relating to the new policy.

According to NHS Supply Chain, improving data on medical devices across the NHS system is a key contributor to improving patient safety through greater and more rapid traceability.

It says that, at the moment, medical device data is not routinely collected in a consistent manner or standardised digital format. Current processes are often paper-based and lack standardisation and validation, which means that tracing medical devices is time consuming and laborious and linking devices to patient outcomes difficult.

NHS Supply Chain’s vision is that a single scan from inventory management systems can be integrated to have many uses across the NHS.

The adoption of global standards, such as GS1, for product identification, enhances the traceability of medical devices and other products used in an episode of patient care. It also means that the clinical time required for product or patient recall is reduced.

The GS1 standards provide a common foundation and consistent format and enables the unique identification, capture, and sharing of information automatically. When data describing medical devices is captured electronically it can be easily associated with a patient and provide accurate information about which devices have been used in their care.

This electronic data capture for product forms part of the NHS England Scan4Safety programme methodology to capture data for person (patient and caregiver), product, place, and procedure.

Access to this data electronically in a standard format enables it to be interrogated and performance of medical devices can be monitored, patient outcomes measured, and any potential issues with devices can be identified faster and more easily allowing clinicians to intervene and if necessary, prevent harm before it happens.

The policy will also support NHS Supply Chain in improving the quality of its critical product data and increasing the number of GTINs it holds for medical products in its catalogue.