Government to adopt EU standards for high-risk diagnostic devices

New regulations aim to simplify processes and strengthen patient safety

The Government is set to amend UK medical devices regulations by adopting EU Common Specifications for high-risk in vitro diagnostic (IVD) devices, including those used for infectious diseases and blood analysis.

This change follows strong support for a proposal to repeal the Coronavirus Test Device Approval (CTDA) process in favour of EU-aligned standards.

An accelerated CTDA process will be introduced in the interim for COVID-19 devices carrying CE marking under European IVD rules and meeting Common Specification…