As the UK continues to develop its own regulatory framework after leaving the European Union, it appears that the medical device industry will be next to see new legislation. The UK Medicines and Healthcare products Regulatory Agency (MHRA) released a roadmap for new regulations in January 2024, outlining the next steps in developing a new framework for medical devices.
The MHRA has been working on new medical device regulations for several years, having originally launched the process with a public consultation in 2021. In the interim, the UK has been operating under the outdated Medical Devices Regulations 2002, which implemented 1990s EU legislation. In announcing the new regulatory roadmap, the MHRA identified three core goals: put patient safety first and help to ensure that patients continue to have access without delay to devices they need; enhance the UK’s position as a world-leading environment for medical technology innovators; and deliver greater international harmonisation.
Key details of the roadmap
The MHRA will roll out new regulations via a series of Statutory Instruments (SIs), starting with regulations for Post-Market Surveillance (PMS) in 2024. The draft PMS SI is in the final stages of the legislative process, and the UK government intends to publish the final SI in early 2024 and expects it to apply near the end of the year. The draft PMS SI that was released last July outlines several key measures, including:
- Details for what must be included as part of a PMS system, including the methods for collecting PMS data to support improved capturing of PMS data and harmonisation across manufacturers.
- Enhanced serious incident reporting obligations for manufacturers to support the detection of safety issues sooner.
- More stringent requirements for manufacturers to conduct periodic reviews of their PMS data, including for implantable medical devices. These requirements aim to support manufacturers in earlier detection of trends/signals that may have an impact on the safety of a medical device.
The MHRA plans to release other core regulations in 2025, which will make up the bulk of the regulatory framework. As identified by the MHRA, the future core regulations will:
- Introduce improvements for implantable medical devices.
- Ensure devices have a unique device identifier (UDI).
- Change the classification of several types of devices.
- Strengthen the requirements for quality management systems and technical documentation.
- Include new requirements for the claims manufacturers can make about their medical devices, requiring them to align with their statement of intended purpose.
- Bring the essential requirements for medical devices being placed on the market in Great Britain into greater alignment with those of the EU.
The medical device industry will have the opportunity to share input on the future regulations, as the MHRA will hold stakeholder discussions in early 2024. The industry should begin reviewing the roadmap and other draft documents released by the MHRA as they await final guidance. Companies who operate in the UK and EU markets should also start considering how the UK regulatory framework is likely to prompt changes in their manufacturing and quality control processes.
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