BIVDA welcomes the replacement of Covid Test Device Approval Scheme.
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.
The MHRA have confirmed they intend to follow the timelines set out in their roadmap, which means the CTDA legislation is likely to remain in place until the end of this year. We recognise that this may place members in a difficult position as they balance the need for market access against the cost and complexity of the CTDA process.
BIVDA’s Director of Policy and Programmes Paul Fisher, says “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.”
BIVDA’s Chief Executive Helen Dent, says: “Whilst we are experiencing a hot summer, we must continue to plan for winter, which is not far away.
“We call on the MHRA to enact this as soon as possible, to allow our industry to supply the cutting-edge tests which will help the NHS manage the seasonal respiratory infections.”
Members can find the MHRA’s press release here.
