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The UK is set to align more closely with European standards on high-risk in vitro diagnostic (IVD) devices, easing the regulatory burden on manufacturers while improving safety and consistency.
Following strong support from respondents to a recent MHRA consultation, the government plans to replace the current Covid Test Device Approval (CTDA) process with new Common Specifications. These specifications, already in use across Europe, will set clearer standards for tests involving infectious diseases like Hepatitis B, C, D, HIV, and Syphilis, as well as for blood grouping and tissue typing.
An accelerated CTDA process will be introduced in the meantime for COVID-19 tests that already carry CE marking and meet these standards.
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.”
BIVDA Director of Policy and Programmes, Paul Fisher, welcomed the move:
“The CTDA was a proportionate response during the pandemic, but replacing it with a system that mirrors European regulations is long overdue. It removes costly and time-consuming steps that have been blocking innovation.”
The regulatory changes are expected later this year as part of the government’s wider medical device reform programme, supporting both the NHS and UK life sciences.
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