The government has said that it will incorporate EU Common Specifications for in vitro diagnostic devices to improve patient safety. 

The government has said that it intends to amend medical devices regulations to incorporate EU Common Specifications for high-risk in vitro diagnostic (IVD) devices. 

It will repeal the current Coronavirus Test Device Approvals (CTDA) process for COVID-19 devices and will replace current requirements with Common Specifications. 

In the meantime, an accelerated CTDA process will be introduced for COVID-19 devices that have CE marking under the European IVD regulations (EU IVDR) and meet Common Specification requirements.

The Common Specifications will also improve performance standards for IVD devices related to infectious diseases, including Hepatitis B, C and D, HIV and syphilis, as well as devices for blood grouping and tissue typing. These diagnostic tools are critical for effective patient care and public health management.

Common Specifications are a set of requirements for high-risk IVD devices that relate to clinical evidence, performance evaluation, analytical and diagnostic sensitivity and specificity, reference materials and measurement traceability, and post-market surveillance.

Overwhelming support

It is a move that was overwhelmingly supported by medical stakeholders, with 92% of respondents to a government consultation on the issue agreeing with the government’s plans. Respondents came from across the country. 

“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,” said Rob Reid, deputy director of innovative devices at the regulator, the Medicines and Healthcare products Regulatory Agency (MHRA). 

The move aims, the government says, to ensure that these vital IVD devices “meet high standards of performance backed by robust clinical evidence”.

These new specifications will be introduced in regulations expected to be published later this year as part of the government’s broader programme of medical devices regulatory reform.