Regulatory challenges of on-line hemodiafiltration

The launch of on-line hemodiafiltration happened at a very peculiar time from the regulatory standpoint. The directives on medical devices were at their very beginning and the medicinal products regulatory regime was considering, after 30 years of operation of Directive 65/65/EEC, whether it was the case to go for greater harmonization. The success in the introduction of the therapy was strictly linked to the possibility of having the entire system approved for the European market according a single procedure. I had the pleasure to be part of the team, which included Dr. Wolfgang Kümmerle and my old friend Dr. Emanuele Gatti, which succeeded in gathering consensus on the classification of the on-line hemodiafiltration system as a medical device.