Navigating the future: what’s next for Medical Device Regulations in the UK

by | Jul 11, 2024 | IMed Consultancy, MDR, PMS, Regulatory updates, UK, UKRP | 0 comments

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The landscape of medical device regulations in the UK has undergone significant transformation in the last few years, aimed at prioritizing patient safety, ensuring access to essential medical devices, and maintaining the UK’s appeal as a hub for medical technology innovation. This comprehensive reform is guided by the response to the 2021 consultation on future medical device regulations and is detailed in the newly published Roadmap towards the Future Regulatory Framework for Medical Devices [1], published in January 2024.

The reform will be rolled out via four statutory instruments, focusing initially on enhancing post-market surveillance (PMS) in 2024, with the core regulatory framework expected to be established by 2025.

Transitional Arrangements

To facilitate a smooth transition to the new regulatory framework, the UK has amended the Medical Device Regulations 2002 to extend the acceptance of CE-marked medical devices on the Great Britain market. Key transitional measures include:

  • CE-marked general medical devices and IVDs compliant with EU directives can be placed on the market until June 2028 and 2030, respectively
  • Class I medical devices can continue to be marketed under certain conditions until 2028 or 2030.

Strengthened Post-Market Surveillance

In 2024, the government plans to introduce new legislation enhancing post-market surveillance (PMS) requirements. The draft PMS Statutory Instrument (SI) includes detailed requirements for PMS systems, serious incident reporting, and periodic reviews of PMS data. These changes aim to ensure timely detection of safety issues and trends, particularly for implantable devices.

Find out more about PMS in our dedicated blog or download our whitepaper “The perfect time to perfect PMS”.

Future core regulations

Stakeholder discussions in the first half of 2024 will shape the future core regulations, informed by previous consultations. The core regulations will introduce several enhancements, including:

Improved classification and identification

Implantable devices will face stricter pre- and post-market requirements. Devices must have a unique device identifier (UDI), and classifications for certain software and IVDs will align with international standards.

Enhanced Quality and Safety

Strengthened quality management systems, technical documentation, and clinical investigation requirements will be mandated. New cybersecurity requirements will also be introduced for software as a medical device, including artificial intelligence.

International Collaboration

A framework for international recognition will facilitate quicker access for devices approved by comparable regulators.

Economic Operator Requirements

New roles and responsibilities for manufacturers, importers, and distributors, including a qualified person for regulatory compliance, will be established.

Roadmap and timeline

The roadmap for 2024-2025 outlines key milestones  and activities in the regulatory overhaul:

  • Early 2024 – Stakeholder discussions on future core regulations, focusing on scope, classification, essential requirements, and international recognition.
  • Mid 2024 – Launch of the AI Airlock regulatory sandbox and publication of PMS guidance.
  • Late 2024 – Publication of SaMD (Software as a Medical Device) guidance and finalization of PMS regulations.
  • Early 2025 – Draft legal text for future core regulations published by the World Trade Organization.
  • Mid 2025 – Future core regulations laid in Parliament.
  • Late 2025 – Implementation and enforcement of future core regulations.

To support the MedTech sector, the government will collaborate with industry stakeholders to provide comprehensive guidance on interpreting and implementing the new regulations. This will ensure that all parties are well-prepared for the upcoming changes.

The upcoming changes to the UK’s medical device regulations are set to enhance patient safety, streamline market access, and foster innovation. By understanding and preparing for these changes, stakeholders can ensure a smooth transition and continued success in the evolving regulatory landscape.

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[1], Roadmap towards the future regulatory framework for medical devices

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