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

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…

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…