CEcertiso is the 12th MDR Notified Body

2020.03.23.

The long notificaton process came to the end phase in last week, From 21.03.2020 CEcertiso Kft. is a the 12th notified body according to the MDR.

The notification covers a wide range of medical devices. In fact, with the exception of active implantable devices, the company has been acquired the notification for almost all device groups.

With regard to conformity assessment procedures, the CEcertiso has received the notification as expected to the follows:

  • the procedure based on the quality management system and the assessment of the technical documentation according to annex IX. and
  • the production quality assurance procedure based on the annex XI.

More details are available here: CEcertiso MDR NB

Congratulations to the CEcertiso team!