The ACM has been validated and complies with the European requirements for medical devices. The ACM was classified as a Class I medical device in accordance with Directive 93/42/EEC. A proof of concept trial was conducted in 3 NephroCare dialysis clinics (managed by Fresenius) in the Czech Republic, Portugal, and Spain. It could be shown that the introduction of ACM-guided therapy led to a significant decrease in median darbepoetin doses and to a significant increase in on-target haemoglobin (Hb) values along with a decrease in Hb fluctuation. Moreover, a retrospective trial conducted in NephroCare clinics in Portugal, suggested that ACM is able to reliably predict the long-term response to ESA and iron therapy in patients undergoing haemodialysis.