With the directorate decree dated December 4, 2025, the scope of the ECM designation was updated, extending this designation to certain types of Class III devices. The complete ECM designation scope is available on the NANDO system.

 

 

CATEGORIES OF CLASS III DEVICES NOW COVERED BY ECM

 

 

The ECM designation is now extended to the following types of Class III Medical Devices:

 

 

Defibrillators

 

 

Non-Active Dental Devices

 

 

Software

 

 

CONTACT US

 

 

Take advantage of this extension of our Notification Scope and contact us to find out if your medical devices fall within our updated Notification Scope.

 

 

Contact our Sales Managers:
Diego Stevanella – diego.s@entecerma.it
Marzia Pellegrini – marzia.p@entecerma.it