We are pleased to inform you that our company has successfully passed the certification according to the Medical Device Regulation (MDR) of the European Union. From 15.01.2024, our product groups Breathing Gas Humidifiers, Heated Breathing Sets and Humidification Chambers will be produced and placed on the market in accordance with the MDR (Regulation EU 2017/745) in compliance with the latest European regulations.
While these selected product groups have been successfully converted to the MDR, we would like to point out that the other product groups will temporarily continue to be operated in accordance with the familiar Medical Device Directive (MDD – Directive 93/42/EEC) until they have also been successfully transferred to the MDR.
You can download the complete press release here.