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Implementation of the future regulations

Updated 2 March 2026

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This publication is available at https://www.gov.uk/government/publications/implementation-of-the-future-regulation-of-medical-devices/implementation-of-the-future-regulations

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
  • bring the essential requirements for medical devices being placed on the market in Great Britain into greater alignment with those of the EU

The pre-market regulations will enable greater international collaboration and align more closely with best practice for patient-centred, proportionate requirements for medical devices which are responsive to technological advances.

4. Future enhancements

More broadly, we are actively working to improve the medical devices regulatory framework and supporting guidance. This includes updates in 2025 to guidance on exceptional use authorisations and the health institution exemption . We are also exploring additional areas for enhancing our regulations and guidance in line with government priorities.

5. Post-market surveillance requirements

In 2024, the government put in place legislation to clarify and strengthen the post-market surveillance (PMS) requirements for medical devices in use in Great Britain. The Medical Devices (Post-market Surveillance requirements) (Amendment) Great Britain) Regulations 2024 came into force on 16 June 2025 and facilitate greater traceability of incidents and trends enabling the MHRA to act swiftly when needed to address safety issues and support the entire health system in better protecting patients.

This legislation introduced new PMS requirements for medical devices that prioritise patient safety, while still giving patients access to the safe medical devices they need and ensuring the UK remains an attractive market for medical technology innovators.

The main changes introduced by this legislation include:

  • detail on what must be included as part of a PMS system, including the methods for collecting PMS data to support improved capturing of PMS data and harmonisation across manufacturers
  • enhanced serious incident reporting obligations for manufacturers to support the detection of safety issues sooner
  • clearer obligations on manufacturers to consider conducting a field safety corrective action (FSCA) to prevent or reduce the risk of a further serious incident, accompanied by detailed requirements relating to field safety notices (FSN) to better target patients and users at risk
  • requirements for manufacturers to conduct periodic reviews of their PMS data, including for implantable medical devices, to support manufacturers in earlier detection of trends/signals that may have an impact on the safety of a medical device

A full impact assessment and equalities impact assessment was prepared for these regulations.

The MHRA published comprehensive guidance on post-market surveillance through extensive stakeholder engagement to support manufacturers to understand their obligations and facilitate smooth implementation of these regulations.

6. Updates to guidance

We work with industry, trade associations, devolved governments, learned societies and the wider medical devices community to support the effective implementation of new regulations. Regulatory changes are accompanied by guidance to help the MedTech sector interpret the new regulatory requirements.

7. Latest news on MedTech regulatory reform

Follow us on LinkedIn for regular updates. We also publish blogs, press releases and news stories whenever we have significant updates. Latest updates include:

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