MHRA Reform 2026: New Requirements for Medical Devices in Great Britain

Date

May 8, 2026

Category

UK Regulations

Description

On 8 May 2026, the Medicines and Healthcare products Regulatory Agency (MHRA) published proposed new requirements for medical devices and in vitro diagnostic devices entering the GB market. The draft text, titled Medical Devices (Amendment) Regulations 2026, was published on the World Trade Organization (WTO) notification portal to allow WTO members to comment.

In parallel, the Medicines and Healthcare products Regulatory Agency (MHRA) is inviting the MedTech industry, approved bodies, healthcare providers and patients to provide feedback through a survey. Responses will inform the Impact Assessment and future implementation of the regulations.

What is proposed?

The proposed changes aim to introduce patient-centred and proportionate requirements that prioritise patient safety while supporting access to innovative medical technologies. Key elements include:

a framework to enable faster access for devices already approved by regulators in Australia, Canada and the USA;
compulsory Unique Device Identifiers (UDI) to enable precise identification and traceability throughout the product lifecycle;
implant cards for patients receiving implanted medical devices, improving transparency and adverse event management;
alignment of IVD classification with International Medical Device Regulators Forum (IMDRF) standards;
alignment of essential requirements for medical devices in Great Britain with international best practice;
stronger requirements for technical documentation retention;
new requirements for custom-made devices to improve traceability and enable electronic prescriptions;
a requirement for manufacturers to align claims about their medical devices with the stated intended purpose.

What does this mean for the medical device industry?

Manufacturers, UK Responsible Persons and other economic operators should assess whether their products and processes may be affected by the proposed changes, particularly regarding market access, UDI, IVD classification, implant cards, technical documentation and product claims.

Do you need support assessing your products for the UK market?