Regulatory pathways for medical devices in Great Britain are set for further change, following the publication of new pre-market requirements by the Medicines and Healthcare products Regulatory Agency (MHRA). The proposals introduce new measures on reliance, traceability and classification as part of the evolving post-Brexit regulatory framework.
Published on 8 May 2026 via the World Trade Operation (WTO) notification portal, the draft Medical Devices (Amendment) Regulations 2026 are now available for comment. Stakeholders, including industry, approved bodies, healthcare providers and patients, are invited to provide feedback through both the WTO portal and an MHRA survey by 19 June 2026.
The proposals form part of the UK’s ongoing regulatory reform programme, which aims to strengthen patient safety while improving access to innovative medical technologies and supporting the growth of the UK MedTech sector. For regulatory affairs professionals, the draft introduces several notable changes with potential operational impact.
A key development is the proposed reliance framework to enable faster access to medical devices already approved in Australia, Canada and the United States. This reflects a stronger shift towards international alignment and may help improve efficiency for international registrations.
The MHRA also proposes making Unique Device Identification (UDI) mandatory. As is already the case in the EU, this update is intended to enhance device traceability across the device lifecycle, adverse event reporting and post-market obligations, with implications for labelling systems, data infrastructure and supply chain processes.
In addition, the draft proposes the alignment of in vitro diagnostic (IVD) device classifications with International Medical Device Regulators Forum (IMDRF) standards, supporting greater international consistency. There are also strengthened expectations around retaining technical documentation and ensuring product claims remain consistent with intended use.
Further proposals strengthen requirements for custom-made devices, including improved traceability and electronic prescriptions, alongside patient-facing measures such as implant cards designed to improve transparency and support safer device use.
Overall, the proposals indicate a shift towards a more streamlined, internationally aligned and traceable regulatory framework. Regulatory professionals are encouraged to review the full draft and assess potential impacts on regulatory strategy and compliance networks ahead of the consultation deadline. Feedback will contribute to the final Impact Assessment and shape implementation.
