The UK government is moving forward with plans to shape the post-Brexit landscape for medicines, medical devices and diagnostics by reforming the legal framework underpinning the regulation of medical devices on the market. The new plans were published on 26 June 2022 and followed an extensive consultation on the future of the regulatory framework in which the Medicines and Healthcare products Regulatory Agency (MHRA) sought feedback on a broad range of issues, including the scope of the regulations, classification of medical devices, conformity assessments, and unique device identifiers (UDIs).
The plans are expected to amend the Medical Devices Regulations 2002 to develop a framework that strikes a balance between promoting safety and safeguarding public health, and fostering responsible innovation in the sector. The intention is to create a new regulatory framework focused on modernising regulation in the industry while remaining aligned with international standards and keeping pace with the rapidly evolving MedTech sector.
Plans to reform
It is expected that the new measures will include the following:
- Expanding the scope of regulations to capture specific non-medical products, such as products for which manufacturers claim only an aesthetic or another non-medical purpose, but which are similar to medical devices in terms of their functioning and risk profile. This range of products is set to include items like dermal fillers and coloured contact lenses, and it is expected that existing systems will be enhanced to provide greater assurances around a products performance and safety.
- Amendments to classification rules for general medical devices to reflect changes in technology (such as invasiveness and potential toxicity of certain devices), ensuring that classification rules are better aligned with best international practice and that scrutiny is proportionate to the level of risk of the device.
- Implementing measures to enhance transparency by increasing information captured and shared at the point of device registration.
- Improving traceability of medical devices through the use of UDIs, including requirements for manufacturers to assign UDIs before placing devices on the market, and cooperation requirements for distributors and importers with a view to developing an appropriate level of traceability for medical devices.
- Introducing additional enhanced requirements for Approved Bodies to ensure they operate at a consistent standard, allowing better uniformity in the scrutiny of devices placed on the market across the UK.
- Introducing measures to improve support for innovation in medical devices, such as improving regulation for software and artificial intelligence (AI) as a medical device to offer alternative and safe routes to market for ground breaking innovations.
- Introducing alternative routes to market, including domestic assurance, to enhance availability of innovative devices and streamline access to the UK market, while maintaining robust standards of patient safety.
- Introducing the UKCA mark with patient safety as its priority, to replace the CE mark for devices placed on the UK market. The aim is for the new mark to represent that global safety, health and environment protection standards have been met for the medical device products that carry it.
- Addressing health disparities and mitigating identified inequities throughout medical devices development and use, for example, by ensuring devices function as intended for a diverse population. In this respect, the Government has also launched a review into the potential equity issues in designing and using medical devices to tackle inequalities and will provide an update in due course.
The new regulations are expected to come into force in 2023. The MHRA expects to gradually phase in the new requirements with transitional arrangements to give the sector time to adapt to the changes. It is expected that there will be continued work and engagement with the industry whilst legislation is refined and changes are implemented.
It is hoped that the new reforms will allow the UK to set itself as a one of the world’s most effective regulators while setting leading global standards and boosting the MHRA’s reputation and partnerships with others.
How we can help
Our team of regulatory and commercial experts regularly advise clients on the medical device regulatory framework, including commercialisation, manufacturing and distribution arrangements. Should you wish to discuss any issues relating to medical device regulation including the planned reforms and how these may affect you, please contact Vincent Buscemi