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Medical devices and IVDs – the dawn of the UK regulatory age

The UK is currently in the midst of ongoing changes to the regulation of medical devices and IVDs, with significant potential impact on pathology professionals. This is a complex overhaul with different aspects being introduced over the coming years. The next step in this process has now been communicated and it’s changed things up, explains BIVDA’s Ashleigh Batchen.

On 28 April, the Department of Health and Social Care laid a new statutory instrument in Parliament amending the current UK Medical Device Regulations 2002.1 This document has been laid in both the House of Commons and the House of Lords and will undergo a debate in each house. If these debates are successful, the statutory instrument will achieve royal assent and come into force on 30 June 2023 (as stated in the draft legislation). 

This is one of multiple legal texts expected to make up the new UKCA regulatory structure, with the following statutory instruments expected over the next year. It is crucial that the momentum provided by this publication is maximised, and there is not a major delay in laying the outstanding pieces of legislation. 

What does this change?

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