The Government has announced its intention to amend the Medical Devices Regulations 2002 for Great Britain to incorporate EU Common Specifications for high-risk in vitro diagnostic (IVD) devices and to repeal regulations on Coronavirus Test Device Approvals (CTDA).
The specifications will establish standards for high-risk diagnostic tests while creating consistency with European regulations and reducing the regulatory burden for UK firms.
Respondents overwhelmingly supported a recent MHRA consultation to repeal the current CTDA process for COVID-19 devices and to replace current requirements with Common Specifications. In the interim, 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 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. The move aims to ensure these vital IVD devices meet high standards of performance backed by robust clinical evidence.
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.
The British In Vitro Diagnostic Association (BIVDA) has explained the reasoning behind the CTDA change, commenting: "The Covid Test Device Approval (CTDA) was introduced during the pandemic as a measure to regulate an influx of new COVID-19 tests. Its retention post-Covid means any test on the UK market which tests for Covid – even as part of testing for other infections – still needs to pass an additional regulatory step unique to UK. This has kept products off the UK market and is costly and time-consuming."
BIVDA’s Director of Policy and Programmes Paul Fisher added: “Before joining BIVDA, as a senior civil servant, I led the CTDA programme during the latter part of the pandemic. While proportionate at the height of the pandemic, its replacement with a system broadly in line with the rest of Europe is extremely welcome and something BIVDA have advocated for some time."