MHRA Consults on New UK Medical Device Regulations

The MHRA has launched a public consultation on draft pre-market regulatory requirements for medical devices and in vitro diagnostic devices entering the GB market. Published on the WTO notification portal on 8 May 2026 and opened to stakeholders on 11 May, the draft Medical Devices (Amendment) Regulations 2026 aim to balance faster patient access with safety, alignment to international standards and growth in the UK MedTech sector.

Among the most commercially significant proposals is a new reliance framework that would enable swifter GB market access for devices already approved by regulators in Australia, Canada and the USA. The draft also makes Unique Device Identifiers (UDI) compulsory for traceability across the device lifecycle, and aligns IVD classifications with International Medical Device Regulators Forum (IMDRF) standards. Essential requirements for medical devices in Great Britain would be brought into line with current international best practice.

Patient-facing changes include a requirement that healthcare organisations issue implant cards to patients receiving medical implants, supporting adverse-event management and transparency. New requirements would also apply to custom-made devices, including provision for electronic prescriptions, and manufacturers would be required to align product claims with their statement of intended purpose. Technical documentation retention rules are also being strengthened.

The MHRA is inviting input from MedTech manufacturers, approved bodies, healthcare providers and patients through a stakeholder impact survey, with responses informing the formal Impact Assessment and shaping implementation. The deadline is 11:59pm UK time on Friday 19 June 2026.

The proposals sit within the Government’s Life Sciences Sector Plan ambition for the UK to become one of Europe’s three fastest routes to MedTech market access by 2030. If adopted, the reliance route in particular could meaningfully reshape commercial launch strategy for manufacturers already cleared in the US, Australia or Canada, and is likely to be the most closely contested element of the consultation.