MHRA invites views on proposed changes to medical device regulation
New pre-market regulatory requirements for medical devices and in vitro diagnostic devices entering the GB market have been published.
New pre-market regulatory requirements for medical devices and in vitro diagnostic devices entering the GB market have been published by the Medicines and Healthcare products Regulatory Agency (MHRA) on the World Trade Organisation notification portal on Friday 8th May 2026.
The notification provides an opportunity for WTO members to comment on the draft pre-market regulatory requirements, titled the draft Medical Devices (Amendment) Regulations 2026.
The MedTech industry, approved bodies, healthcare providers and patients are also invited to share their views on the impact of the proposed changes via an MHRA survey.
Responses will inform the Impact Assessment and future implementation of the regulations.
The draft Medical Devices (Amendment) Regulations 2026 bring forward patient-centred and proportionate regulatory requirements to prioritise patient safety and access to innovative medical technologies. They are designed to:
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give faster access to safe and innovative medical devices and support economic growth and innovation in the UK MedTech sector.
- introduce a framework to enable swifter access for devices already approved by regulators in Australia, Canada and the USA.
- require healthcare organisations that implant medical devices to give patients implant cards that provide information about the device that was implanted, improving ability to manage adverse events, and transparency for patients.
- make unique device identifiers (UDI) compulsory to enable precise identification and traceability of devices throughout their lifecycle.
- align classifications of in vitro diagnostic (IVD) devices with those of the International Medical Device Regulators Forum (IMDRF) standards.
- align the essential requirements for medical devices in Great Britain with best international practice.
- strengthen the requirements for technical documentation retention to ensure this information is kept for an appropriate period.
- include new requirements for custom-made devices to improve traceability and enable electronic prescriptions.
- require manufacturers to align claims about their medical devices with their statement of intended purpose.
These proposals support the Government ambition, outlined in the Life Sciences Sector Plan, for the UK to become one of the top three fastest countries in Europe to access MedTech by 2030, while safeguarding patient access to medical devices.
The MHRA values any views that are relevant to you or your organisation. Please respond to the survey by 11:59pm (UK time) on Friday 19 June 2026.