Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what steps her Department is taking to improve the regulatory environment for medical devices and technology.

The Medicines and Healthcare products Regulatory Agency (MHRA) is progressing reforms to the Medical Devices Regulations 2002. These are outlined in the Government response to the consultation on the future regulation of medical devices in the United Kingdom published in June 2022.

On 9 January, the MHRA published a roadmap, which sets out a clear path for the development of new and robust regulations for medical devices over 2024 and 2025. The new regulations will put patient safety first, whilst enhancing the United Kingdom’s position as a world-leading environment for medical technology innovators.

In September 2023, the Department, in partnership with the MHRA, the National Institute of Care Excellence, NHS England, Health Technology Wales and Scottish Health Technology Group, launched the Innovative Devices Access Pathway pilot. The pilot provides an accelerated pathway for innovative technologies that meet an unmet need in the National Health Service, including regulatory and support to streamline their adoption into the NHS.