Chemycal has been acquired by 3E

Learn More

In vitro diagnostic medical devices - common specifications | Feedback period 09 February 2022 - 09 March 2022


Your substances

None


These common specifications for certain class D (highest risk) in vitro diagnostic medical devices set uniform and consistently high requirements for device performance across the Union.

The devices covered are those for detecting and/or quantifying HIV, human T-cell lymphotropic virus, hepatitis B, C, D, vCJD, cytomegalovirus, Epstein-Barr virus, Treponema pallidum (syphilis), Trypanosoma cruzi (Chagas disease) and SARS-CoV-2 and for determining ABO, Rhesus, Kell, Kidd and Duffy blood groups.

CONTINUE READING ON: ec.europa.eu
                   

Related News

Loading...