Common specifications are detailed practical rules setting out how particular types of devices should comply with certain requirements of Regulation (EU) 2017/746. The European Commission can adopt common specifications where
- no harmonised standards exist, or
- relevant harmonised standards are not sufficient, or
- there is a need to address public health concerns
Manufacturers must follow the specifications or show that they have adopted solutions of a level of safety and performance that is at least equivalent. To allow market actors to adapt to new specifications, there is a transition period in which their use is voluntary.
List of common specifications adopted under the Regulation:
- Commission Implementing Regulation (EU) 2022/1107 of 4 July 2022, covering devices detecting and/or quantifying HIV, human T-cell lymphotropic virus, hepatitis B, C, D, variant Creutzfeldt-Jakob disease (vCJD), cytomegalovirus (CMV), Epstein-Barr virus (EBV), Treponema pallidum (causative agent of syphilis), Trypanosoma cruzi (causative agent of Chagas disease) and SARS-CoV-2, as well as for determining ABO, Rhesus, Kell, Kidd and Duffy blood groups.