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New draft GB Medical Device Regulation available for comment and feedback

  • Area of Work: The ALLIANCE
  • Type: News Item
  • Published: 28th May 2026

Patient groups, patients and carers are invited to share their views.

The Medicines and Healthcare products Regulatory Agency (MHRA) plan to update the GB Medical Device Regulations, which are due to start their passage through Westminster by the end of this year.

The MHRA are welcoming feedback from parents and carers on the proposed regulation, and there is a section in the Stakeholder Survey specifically for patients, patient groups and carers to provide their feedback.

The MHRA aim that the draft Medical Devices (Amendment) Regulations 2026 will bring forward patient-centred and proportionate regulatory requirements to prioritise patient safety and access to innovative medical technologies. These proposals build on earlier public consultations and engagement undertaken by the MHRA.

Some key medical device regulatory developments will be the mandatory requirements for manufacturers to use a unique device identifier on implants, and for all healthcare providers (both NHS and private providers) to keep all the device details of any implants linked to the patient identifier. In addition, the draft regulation also proposes that for every implant, a patient must be provided with an implant card with all the details of their implant and a patient information leaflet that provides them with key information about their implant.

You can access the draft regulations here: MHRA invites views on proposed changes to medical device regulation – GOV.UK

The deadline to provide feedback is Friday 19 June, 11.59 am.

For further information and to access the MHRA survey and guidance, visit the link.

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