House of Commons · Written Ministerial Statement
Medical Devices Update
27 June 2022 · Department of Health and Social Care
Proposed by Sajid Javid Con Bromsgrove
Summarised by AI from the official record, so it can contain mistakes.
At a glance
Key points
- The UK government has published a consultation response to improve the medical device regulatory regime post-Brexit.
- The changes aim to support innovation in the life sciences sector and enhance patient safety.
- A review by Dame Margaret Whitehead will address equity issues in the medical device industry.
Issue summary
The statement discusses the UK's plans to improve its medical device regulatory regime following Brexit, focusing on patient safety, innovation support, and public health safeguards.
Action requested
The government has published a consultation response outlining changes to support innovation in the life sciences sector, address equity issues through a review by Dame Margaret Whitehead, and implement transitional measures for industry preparation. The UK Conformity Assessed (UKCA) marking is being built as a global exemplar with phased transition plans.
Key facts
- The consultation received 900 responses.
- The Medicines and Healthcare Products Regulatory Agency (MHRA) analysed the responses.
- A review into equity in medical device design and use was appointed to Dame Margaret Whitehead.
- Transitional measures will support access to safe medical devices during industry preparation.