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

CLASS III DEVICE CATEGORIES NOW FALLING WITHIN THE ECM SCOPE

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

• Non-Active Dental Devices
• Software
• Defibrillators

CONTACT US

Take advantage of this extension to 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