A telemedicine system for home haemodialysis was designed using a systems approach and a feedback model to produce the hardware and software specifications. Preliminary clinical trials at four European locations involved 29 patients and 305 sessions of haemodialysis. The evaluation included an evaluability assessment and formative evaluation. Central to the methodology was the detailed specification of a stakeholder/evaluation criterion matrix. Preliminary results indicated that the telemedicine system was capable of satisfying the requirements of formative evaluation as a precursor to evaluating its overall worth.