Common specifications are a set of technical and/or clinical requirements that provide a means of complying with the legal obligations applicable to a in vitro diagnostic medical device, process or system. They are used when no harmonized standard is available or the harmonized standard insufficiently covers the requirements. The EU Commission has adopted new common specifications for several types of Class D IVDs, which provide clarity on requirements related to minimum performance characteristics, number of tests per method claimed by the manufacturer, qualification criteria, acceptance criteria and more.
Common Specifications are laid down for the following types of Class D IVDs:
- Devices intended for detection of blood group antigens in the ABO, Rh, Kell, Duffy and Kidd blood group systems.
- Devices intended for detection or quantification of markers of human immunodeficiency virus (HIV) infection.
- Devices intended for detection or quantification of markers of human T-cell lymphotropic virus (HTLV) infection.
- Devices intended for detection or quantification of markers of hepatitis C virus (HCV) infection.
- Devices intended for detection or quantification of markers of hepatitis B virus (HBV) infection.
- Devices intended for detection or quantification of markers of hepatitis D virus (HDV) infection.
- Devices intended for detection of markers of variant Creutzfeldt-Jakob disease (vCJD).
- Devices intended for detection or quantification of markers of cytomegalovirus (CMV) infection.
- Devices intended for detection or quantification of markers of Epstein-Barr virus infection (EBV).
- Devices intended for detection of markers of Treponema pallidum infection.
- Devices intended for detection or quantification of markers of Trypanosoma cruzi infection.
- Devices intended for detection or quantification of markers of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection.