Latest developments on the future of the UK Medical Devices Regulations

The United Kingdom is moving towards a new framework for medical devices and IVDs. In the last months, the MHRA has released a decisive public consultation to address provisions for medical devices and IVDs, whereas its regulatory reform roadmap was published just in December 2024. These latest developments come immediately after the proposal of revised post-market surveillance requirements in October 2024.

Public consultations: key proposal for a new UK MDR

In November 2024, the MHRA launched a consultation on several provisions of the UK regulatory framework for medical devices (UK MDR), with responses due by 5 January 2025. Specifically, the consultation covers pre-market provisions for medical devices and IVDs.

Key proposals addressed in this consultation include:

  • Potentially removing the requirement for UKCA marking on devices undergoing UK conformity assessments
  • Exploring international reliance routes for medical devices compliant with regulations in countries like Australia, Canada, the USA, or the EU
  • Evaluating whether regulatory requirements for IVDs, particularly Class B devices, are proportionate to their risk class.
  • Seeking input on retaining certain EU regulations, such as specifications for IVDs, electronic instructions for use, and requirements for devices using animal-origin tissues, within the UK statutory framework until a new regime is implemented.

Roadmap to implementation of medical devicesā€™ reform

In December 2024, the MHRA released a new version of its Medical Devices Regulatory Reform Roadmap, outlining updates to medical device regulations with specific upcoming timelines:

  • Post-Market Surveillance (PMS): The initial guidance will be issued by March 2025, with final guidance in June 2025. The Regulations will apply mid-2025, six months after becoming law.
  • Pre-Market Requirements: Public consultation responses will be released in early 2025 and the new requirements implemented by 2026.
  • Policy Development: Exceptional Use Authorisation (EUA) guidance will be released by March 2025. Policies supporting innovation and early access, as well as the IVD roadmap, will be finalised during 2025.
  • Regulations on Software and AI: Guidance for AI, cybersecurity, and digital mental health technologies will be released for comment in early 2025, with refinements continuing throughout the year.

     

 

Do you have questions on compliance of medical devices in the UK? Contact us here.

 


Regulatory Intelligence & InnovationĀ Ā Ā 

23/12/2024

References:

MHRA (2024). Medical Devices Regulatory Reform. Retrieved on 23/12/2024.

MHRA (2024). Consultation on Medical Devices Regulations: Routes to market and in vitro diagnostic devices. Retrieved on 23/12/2024.

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