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MHRA launches public consultation on common specifications for high-risk IVDs

By June 12, 2024No Comments

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. This would avoid duplication of regulatory requirements for COVID-19 test devices.

The common specification policy intends to improve the safety profile of high-risk IVDs and bring consistency with the EU regulations.

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.

Ben Kemp