Ascom’s Unite Connect for Clinical Systems has obtained the medical device product certification (class IIb) according to the Medical Device Regulation (MDR) of the European Union.
The certification encompasses Unite Connect for Clinical Systems, Unite Axess for Smart Devices and Unite View. These are medical devices which provide an interface with clinical systems to communicate information, including vital physiological parameters, associated with particular events to designated display devices in order to support monitoring of patients.
In addition to the MDR certification of Unite Connect for Clinical Systems, Ascom also received a class IIb certification for the External Input Module. In combination with specific room controller software, the External Input Module aims to interface with primary medical devices approved for communication of alarm conditions in order to provide automated, reliable, near real-time visual indication of alarm conditions to corridor lamps in Ascom’s Telecare IP nurse call system.
The new MDR came into force in 2017 and has been applicable since 26 May 2021, replacing the prior Medical Device Directive (MDD). The new regulation ensures a consistently high level of health and safety protection for EU citizens using medical devices. Furthermore, MDR has been adapted to the technological and scientific progresses which have occurred in this sector over the last 20 years. Therefore, the MDR certified medical devices ensure a significantly higher level of quality and safety compared to MDD certified devices. An MDR certification is applicable in all EU and EFTA member states.
Nicolas Vanden Abeele, Ascom CEO, says: “Following the MDR certification of Digistat Care beginning of 2022, this is another important validation for our alarm management solutions that support clinical staff where it’s really needed. We are proud to have obtained these certifications, and they confirm Ascom’s cutting-edge technologies for clinical solutions.“