The MHRA have launched a 4-week public consultation on common specification requirements for high risk IVDs.
They are seeking views on the inclusion of these requirements for certain high-risk IVDs and on the removal of the Coronavirus Test Device Approval (CTDA) process from UK MDR 2002.
The common specification policy intends to improve the safety profile of high-risk IVDs and bring consistency with the EU regulations.
The potential removal of CTDA is a positive step, as the problem it was designed to tackle – a rapid influx of low-quality tests – is no longer an issue. BIVDA has advocated for this for some time and are delighted to see the MHRA responding.
BIVDA members are encouraged to respond to this consultation directly using this link by Friday, 14 June 2024.
If you have any questions, please contact regulatory@bivda.org.uk.
