The proposal to repeal the current CTDA process for Covid-19 devices and to replace current requirements with common specifications was 'overwhelmingly supported', the government said.

In the interim, an accelerated CTDA process will be introduced for devices that have CE marking under the European IVD regulations (EU IVDR) and meet common specification requirements.

The common specifications will also enhance 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. 

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.'

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, which supports the NHS transformation.

The changes reinforce the Government's commitment to reduce regulatory burden and balance robust patient safety measures with support for innovation in the medical technology sector.