UK New Medical Device Regulation Implementation

1. Overview: Implementing the future regulations

The government is introducing new regulations for medical devices that prioritise patient safety, give patients and healthcare professionals rapid access to the most innovative medical devices available and support growth and innovation in the MedTech sector.

The approach to these reforms was outlined in the government response to the 2021 consultation on the future regulation of medical devices in the UK and in the 2025 responses to the consultation on routes to market and in vitro diagnostic devices and the consultation on common specification requirements for in vitro diagnostic devices. The government will ensure that there is a proportionate, phased approach to the implementation of the future regulatory framework, which supports system readiness and minimises the risk of supply disruption for UK patients.

The updates to the regulations are incremental and are being delivered though secondary legislation.  Updates to post-market surveillance requirements were made in 2025 and a further statutory instrument will follow in 2026 to introduce new pre-market requirements including an international reliance scheme. Future legislation and guidance will deliver further enhancements to the GB regulatory framework.

2. Consultation on indefinite recognition of CE marked medical devices and current transitional arrangements

We have published a consultation on proposals for indefinite recognition of CE marked medical devices in Great Britain which is open from 16 February to 10 April 2026.

The consultation seeks views on proposals to indefinitely extend transitional arrangements that were put in place in 2023. See Timelines for acceptance of CE marked medical devices in Great Britain (GB).

3. Pre-market Statutory Instrument (SI)

The Government response to our Consultation on Medical Device Regulations: Routes to market and in vitro diagnostic devices was published in two parts on 26 February 2025 and 22 July 2025. The results have informed the planned statutory instrument on pre-market requirements which will introduce additional measures before a device can be put on the market.

These ‘pre-market’ regulations will:

- introduce a new framework for international reliance, enabling swifter access for devices already approved by comparable regulators

- introduce several improvements for implantable medical devices; with risk-proportionate requirements and a requirement for manufacturers to provide implant cards for patients

- require devices to have unique device identifiers (UDI)

- change the classification of several types of devices, including aligning IVD classifications with those of the International Medical Device Regulators Forum

- strengthen the requirements for technical documentation

- include new requirements for custom-made devices

- include new requirements for the claims manufacturers can make about their medical devices requiring them to align with their statement of intended purpose