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Medical Devices Update
27 June 2022
Type
Written Ministerial Statement
Department
Department of Health and Social Care
At a Glance
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.
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Assessment & feedback
Summary accuracy