Monidor's remote monitoring software has been granted an MDR certificate

The certificate, obtained on August 15, 2024, is proof of the remote monitoring software's compliance with the European Union's Medical Device Regulation (Class IIa). The certification also includes approval for the Monidrop W device. The certification process involved extensive documentation, detailed descriptions of processes and devices, as well as audits.

The MDR regulation has tightened the EU's requirements for medical devices and software, replacing the previous MDD directive. Its aim is to harmonize EU-level regulations and enhance patient safety.

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