Question to the Department of Health and Social Care:

To ask Her Majesty's Government what plans they have to follow the approach of the government of the United States' Food and Drug Administration in adapting regulatory requirements by putting clinical evidence into the post-market approval phase and improving the introduction of medical innovation devices.

The Medicines and Healthcare products Regulatory Agency (MHRA) is will conduct a public consultation this summer on the future medical device regulatory regime. This consultation will inform future amendments made to the United Kingdom Medical Device Regulations 2002 as required under the Medicines and Medical Devices Act 2021. The public consultation will cover various aspects of the medical device regulations, including requirements relating to clinical investigations and evidence. The MHRA is committed to ensuring that both pre- and post-market standards are enhanced to protect UK patients whilst supporting innovation with greater alignment with international standards for pre-market clinical data. This will ensure that the domestic medical devices regime remains fit for purpose in an evolving public health environment and facilitates a sector that embraces innovation.