Reforming Medical Device Regulation in the UK: Implementation of the Future Regime

1. Background and objectives

The UK government is implementing a future regulatory framework for medical devices to prioritise patient safety, maintain access to necessary technologies, and ensure the UK remains an attractive market for medical technology innovators. This initiative responds to a public consultation on the future regulation of medical devices and outlines how reforms will be introduced gradually to support system readiness and minimise supply disruption for UK patients.
Source: Implementation of the future regulation of medical devices (gov.uk)

2. Timeline and legislative approach

The future regime will be implemented through secondary legislation, with multiple statutory instruments laid before Parliament over 2024, 2025 and 2026.

• The first piece of legislation introduced in 2024 updated post-market surveillance (PMS) requirements to strengthen how safety issues and incident trends are monitored once devices are in use.
• Subsequent statutory instruments in 2025 and 2026 will introduce new pre-market requirements, including international reliance provisions and further regulatory enhancements.
  These phased legislative milestones aim to balance regulatory enhancement with continuity of supply.
  Source: Implementation of the future regulation of medical devices (gov.uk)

3. Transitional arrangements

To ease the transition to the new regulatory framework, the government has amended The Medical Device Regulations 2002 (UK MDR) to extend acceptance of CE-marked devices in the Great Britain market. The transitional timelines include:

• CE-marked general medical devices compliant with the EU Medical Devices Directive or Active Implantable Medical Devices Directive may be placed on the Great Britain market until the earlier of certificate expiry or 30 June 2028.
• CE-marked in vitro diagnostic medical devices (IVDs) compliant with the EU IVDD may be placed until the earlier of certificate expiry or 30 June 2030.
• CE-marked devices compliant with the EU MDR or EU IVDR can generally be placed until 30 June 2030.
  These transitional provisions aim to support ongoing supply while allowing time to adopt the future regime.
  Source: Implementation of the future regulation of medical devices (gov.uk)

4. Strengthened post-market surveillance

A key step in the future regime was the Post-market Surveillance Statutory Instrument, signed into law in December 2024, which updates and clarifies post-market surveillance requirements for medical devices in Great Britain. This legislation will come into force on 16 June 2025 and will:

• Enhance traceability of incidents and trends, enabling the MHRA to act swiftly to address safety concerns.
• Require more robust monitoring of devices once in use, aligning regulatory expectations with evolving patient safety needs.
  Such changes are integral to the future regime’s focus on safety throughout the life cycle of devices.
  Source: Implementation of the future regulation of medical devices (gov.uk)

5. Development of future core regulations

The MHRA has published a Roadmap towards the future regulatory framework for medical devices, first released in January 2024 and subsequently updated in December 2024, to provide industry with a clear view of the intended implementation timeline and sequence of reform deliverables. This roadmap outlines the planned sequence for future legislative development and associated consultations on routes to market and IVD regulation.
Source: Implementation of the future regulation of medical devices (gov.uk)

6. Policy intent on international recognition

Part of the future regime’s policy work includes a statement of policy intent on international recognition, which explores how recognitions by other regulators (such as EU MDR/IVDR, US FDA, and other competent authorities) could be incorporated into UK regulatory routes, offering alternative access pathways for certain device classes and strengthening global harmonisation efforts.
Source: Statement of policy intent: international recognition of medical devices (gov.uk)

7. Impact for stakeholders

For manufacturers and other stakeholders, the phased approach to implementation means:

• Regulatory clarity and certainty as the new regime is introduced step by step.
• Extended transitional periods to accommodate legacy CE-marked devices while the future framework becomes operational.
• Enhanced safety focus, with stronger requirements for post-market surveillance.
  Manufacturers are advised to monitor forthcoming statutory instruments and ensure readiness for compliance as the future regime takes effect.
  Source: Implementation of the future regulation of medical devices (gov.uk)

8. Conclusion

The implementation of the future medical devices regime in the UK represents a phased, proportionate reform of the existing regulatory system. By combining transitional arrangements, legislative updates, and enhanced post-market surveillance, the UK is preparing to strengthen its regulatory framework in a way that supports patient safety, innovation, and market access continuity.
Source: Implementation of the future regulation of medical devices (gov.uk)