Diagnostics industry helps MHRA shape IVDs roadmap as part of future UK regulation

“We’re waiting for the first statutory instrument (SI),” said Ashleigh Batchen. “That’s a crucial next step as the UK continues to build its standalone medtech regulatory system, and would solidify that we have the [new] date of application,” BIVDA’s head of regulatory affairs told Medtech Insight.

The new date of application of the UK system will be 1 July 2024, a year later than initially planned by the Medicines and Healthcare products Regulatory Agency (MHRA). The deferral was suggested by the agency’s chief healthcare quality and access office Laura Squire in autumn 2022.

But as yet, nothing is official, meaning that companies and their legal departments cannot plan with certainty. Many in the industry feel that even an extra year, while being something of a relief, would still not bring medtech manufacturers into any sort of comfort zone.

This extra time for compliance would be implemented by the first of three SIs that will be the basis of the UK’s regulatory system. The second SI would be on post-market surveillance (PMS), and the third, and most important, would implement the bulk of the new regulatory system. These steps were explained by the MHRA in a recent online seminar.

Batchen and BIVDA chief executive Doris-Ann Williams expect significant progress for the UK system in February. In January, the MHRA said it planned to focus on UK-approved body capacity and mechanisms to advance innovation, and on gaining a better understanding of the scope available to admit selected medtech products approved in other jurisdictions onto the UK market.

More within