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.

The Medicines and Healthcare products Regulatory Agency (MHRA) has published an updated response to its consultation on statutory fees for medical devices, confirming that a new annual registration fee to support post‑market surveillance (PMS) activities will take effect from 1 April 2026. This article summarises the changes for BHTA members.

What is changing

From 1 April 2026, an annual medical device registration fee will be charged per Global Medical Device Nomenclature (GMDN) level 2 category under which a manufacturer has registered products. Where no level 2 exists, level 1 will apply.

The MHRA has confirmed that this new fee will replace the current one‑off medical device registration fee and will be calculated on the categories recorded on 1 April each year, with pro‑rata charges for any new categories added mid‑year.

The MHRA has indicated an estimated amount of £300 per category from 1 April 2026 per GMDN level 2 category (or level 1 category where no level 2 exists), and has noted that approximately 60 percent of manufacturers are expected to pay a single charge.

See the updated response, published 2 September 2025, for more information: ‘MHRA consultation on statutory fees — proposals on ongoing cost recovery: updated government response’.

The one‑off device registration fee remains in place until 31 March 2026. Current schedules, including the £261 medical device registration fee, are set out on the ‘Current MHRA fees’ page.

Why the model has changed

In its original consultation, published on 29 August 2024, the MHRA proposed an annual medical device registration charge modelled at £210 per GMDN code to fund PMS activities. Feedback from industry, including trade associations, questioned affordability and fairness across different device portfolios.

The revised approach, set at GMDN level 2, is intended to distribute costs more equitably while maintaining patient safety and supporting innovation. The consultation documents and background are available at ‘MHRA consultation on statutory fees — proposals on ongoing cost recovery’ and in the original consultation paper ‘MHRA consultation on statutory fees’.

How the new fee will be applied

Under the updated model, a manufacturer will pay once per relevant GMDN level 2 category for the charging year from 1 April to 31 March. If additional categories are added during the year, the charge for those categories will be applied on a pro‑rata basis for the remainder of the year.

Before billing begins, the MHRA will invite manufacturers to take part in a data‑cleansing exercise so they can remove obsolete or withdrawn products from the register without charge. Further guidance will be published by the MHRA to explain scope, billing mechanics, and preparation steps, according to the organisation.

The MHRA has stated that fees will continue to be paid through the Device Online Registrations System (DORS). BHTA members should ensure internal payment processes are ready for the new annual billing cycle.