S.L. 427.16 Art. 3that they are by the the art. They in terms of diagnostic of known The must be or available

The devices must be designed and manufactured in such a way suitable for the purposes referred to in regulation 3.1.3, as specified manufacturer, taking account of the generally acknowledged state of must achieve the performances, in particular, where appropriate, analytical sensitivity, diagnostic sensitivity, analytical specificity, specificity, accuracy, repeatability, reproducibility, including control relevant interference, and limits of detection, stated by the manufacturer. traceability of values assigned to calibrators and, or control materials assured through available reference measurement procedures and, reference materials of a higher order