Class IIb MDR Certificate for Monidor Vitals

Monidor reached a major milestone when the Monidor Vitals remote monitoring software for vital signs was certified as a MDR (Medical Device Regulation) compliant medical device in December 2024. The certification brings the Monidor Vitals software into the class IIb category of medical devices. This achievement is a testament to the high quality of Monidor's development work and its persistent efforts at the forefront of health technology innovation.

Remote patient monitoring in inpatient wards and home healthcare is growing rapidly around the world. It is used to promote patient safety and reduce the workload of healthcare staff. In numerous discussions with healthcare professionals, we have seen that there is also a need and interest for such solutions in Finland.

The clinical trial of Monidor Vitals was conducted at Savonlinna Central Hospital during the summer of 2024. The first implementations of the now certified software will take place in early 2025.

The certificate was issued by SGS FIMKO Oy (Notified Body 0598).

For more information: Mikko Savola, CEO, mikko.savola@monidor.com