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 criteria.
The revised standards will boost consistency across borders and raise performance benchmarks for tests linked to HIV, hepatitis, syphilis and other conditions.
Rob Reid, Deputy Director of Innovative Devices at the MHRA, said: “By aligning with standards already in place across Europe, we’re not only enhancing patient safety but also making it easier for manufacturers to navigate regulatory requirements across different markets.”
The update will ensure high-risk diagnostics are supported by robust clinical evidence, enabling safer and more effective tools for monitoring and treating disease.
Final regulations are expected later this year as part of broader reforms supporting NHS innovation and service transformation.
The move aims to reduce red tape while promoting high-quality medical technologies that address public health priorities across the UK.
