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The UK's Medicines and Healthcare Products Regulatory Agency (MHRA) has published the draft Medical Devices (Amendment) Regulations 2026 and invited stakeholders to comment on the proposed changes. The draft regulations introduce new pre-market requirements for medical devices and in vitro diagnostic (IVD) devices placed on the Great Britain market. Stakeholders can submit their views via an MHRA survey until 19 June 2026.

The proposals aim to strengthen patient safety, improve device traceability and support innovation while facilitating access to medical technologies. According to the MHRA, these measures are part of the UK's broader programme to modernise medical device regulation and establish a new regulatory framework for Great Britain.

Part of Wider UK Medical Device Reform

This is part of the UK’s wider medical device regulatory framework reform following its departure from the European Union. Since 2021, the MHRA has conducted a series of consultations on the future regulation of medical devices. The current proposals build on the agency's roadmap for reform, which was published in December 2024, and follow the introduction of updated post-market surveillance requirements in June 2025.

The MHRA questionnaire identifies several key areas covered by the draft regulations, including device classifications, essential requirements, technical documentation, software as a medical device, IVD regulation, international reliance, unique device identifiers (UDIs), electronic instructions for use, implant cards, custom-made devices and claims made by manufacturers.

Key Proposed Changes

According to the MHRA, the draft regulations would introduce a framework allowing faster access to devices already approved by regulators in Australia, Canada and the United States. The proposals would also make UDI systems mandatory to improve device identification and traceability throughout the supply chain.

Other measures include aligning IVD classification rules with the principles of the International Medical Device Regulators Forum (IMDRF), updating essential requirements for medical devices, strengthening requirements  for the retention of technical documentation, introducing new provisions for custom-made devices, and requiring manufacturers to ensure that claims about devices are consistent with their intended purpose.

The proposals would also require healthcare organisations that implant medical devices to provide patients with implant cards containing information about the implanted device.

Consultation Period

The MHRA is seeking feedback from manufacturers, approved bodies, healthcare organisations, UK Responsible Persons, patients, and other stakeholders. Responses will be used to inform the agency's impact assessment and the future implementation of the regulations. Comments submitted through the MHRA survey are accepted until 19 June 2026.