Diagnostics Industry Helps MHRA Shape IVDs Roadmap As Part Of Future UK Regulation

UK regulatory update from industry and MHRA: February 2023

13 Feb 2023

The MHRA will build its new UK system of medtech regulation on seven regulatory pillars, one of which is an IVD roadmap, says diagnostics industry association BIVDA. The trade body gave an update on the focus groups, UKAB numbers and timings for three awaited statutory instruments.

“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...