DIAGNOSTICS
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? The medical device and IVD industries were previously working to the assumption that the new UKCA regime would apply from 1 July 2024. The initial legal text referenced a date of application of 1 July 2023, which MHRA later confirmed would be extended by 12 months. This new statutory instrument has removed any reference to a date of application, meaning there is currently no legal date of application for the new UKCA regime.
However, MHRA has indicated in some of its guidance documents that it is aiming to have core aspects of the regulation applicable from 1 July 2025.2
This new legal text also amends the
current transitional timelines for existing CE and UKCA marked medical devices and IVDs.
Assuming this legislation passes
through Parliament without any amendments, the new transition periods will be: n Transition for CE MDD or AIMDD products*: Can continue to utilise CE declaration of conformity to place on the GB market until 2028, or until expiry of the certificate (whichever
With conformity assessment reviews in the EU taking longer than expected due to the increased requirements, there is potential for a shortage of products for UK hospitals and laboratories.
WWW.PATHOLOGYINPRACTICE.COM JUNE 2023 23
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