MHealth solution receives CE Mark

MHealth solution receives CE Mark

Copenhagen, Denmark – 16 February 2016.  Monsenso ApS, a technology leader in mobile health solutions for mental health, today announced that last Friday, its mHealth solution received a CE Mark. The double-loop treatment platform that supports the treatment of major psychiatric disorders received a Class 1 Medical Device Certification under the EU Medical Devices Directive.

The certification has been obtained due to the support received from the Market Development Fund (MMF) in May 2015, which granted 2.9 million to DKK for Monsenso and its partners to obtain the necessary certifications for the solution to be ready for an international launch.

With regards to obtaining the CE Marking Certification, Thomas Lethenborg, CEO at Monsenso, commented “Obtaining this certification is an important milestone for Monsenso since our mHealth solution is based on solid research and has already been clinically validated. Our objective with this certification is to be regarded as a medical application rather than just another app.”

A CE Marking Certification guarantees that a manufacturer’s product meets the essential requirements of all relevant European Medical Device Directives.
“Holding a CE Marking Certification and offering a high level of data security is a demand from our customers across the globe. Therefore, it is important that Monsenso can distinguish itself from all other apps with no clinical evidence or inadequate security measures” added Mr. Lethenborg.

The next step for Monsenso is to obtain the ISO 27001 Data Security Certification, the ISO 13485 Certification, and to become HIPAA and FDA compliant, which is also part of the support granted by the MMF funding.


For additional information contact:
Jennifer Highland
Marketing and Communications Manager
+45 81 71 7713

You can download this article as PDF in English and Danish