Following the UK's exit from the European Union, the government aims to improve how medical devices and diagnostic devices are regulated through a new framework. The MHRA held a consultation on the future regulation of medical devices in the UK in autumn 2021 and this report outlines the government's response to the consultation.
The consultation received 891 responses and aimed to collect views on developing a future legislation for medical devices which delivers:
- improved patient and public safety
- greater transparency of regulatory decision making and medical device information
- close alignment with international best practice, and
- more flexible, responsive and proportionate regulation of medical devices.
The new framework for regulation of medical devices in the UK will be built on five pillars:
- Strengthening MHRA power to act to keep patients safe
- Making the UK a focus for innovation, the best place to develop and introduce innovative medical devices
- Addressing health inequalities and mitigating biases throughout medical device product lifecycles
- Proportionate regulation which supports businesses through access routes that build on synergies with both EU and wider global standards
- Setting world leading standards – Building the UKCA mark as a global exemplar
Key points in the government's response include:
- In light of strong support for proposals that improve patient safety, the MHRA will prepare regulations that reclassify products such as certain implantable devices, extend the scope of regulations to capture certain non-medical products with similar risk profiles to medical devices (eg. dermal fillers, coloured contact lenses) and strengthen and increase post-market surveillance requirements ensure better incident monitoring reporting and surveillance.
- The MHRA recognises that there is strong support for improved traceability of medical devices, including the use of Unique Device Identification (UDI).
- The MHRA aims to support innovation in medical devices, and access to medical devices. It aims to improve regulation of novel and growing areas such as software (including artificial intelligence (AI)) as a medical device to offer alternative and safe routes to market for game changing innovation.
- The MHRA highlights strong support to introduce routes to market which avoid duplication and minimise burden on industry, promoting international collaboration with like-minded regulators while maintaining regulatory oversight. They also note support for a pre-approvals route for innovative devices. The government will also be introducing alternative routes to market, including domestic assurance, to enhance the supply of devices while retaining appropriate levels of scrutiny to ensure patient safety remains a priority.
- The MHRA recognises the role of regulatory standards for equitable outcomes and will provide extended guidance on how manufacturers of medical devices, including software and AI medical devices, can demonstrate and ensure the safety and efficacy of their products across diverse populations.
- Due to the scale of the changes, the government will take a step by step transition to the new framework.