Following a thorough documentary analysis, on February 16, 2026, ECM submitted an official communication to the Ministry of Enterprises and Made in Italy (MIMIT) and, for information, to the Ministry of Health. The objective is to resolve certain discrepancies found on the European NANDO portal compared to the provisions of the Ministry of Health Decree dated December 4, 2025.

Specifically, the request signed by Eng. Vanessa Biavati concerns the update of certain designation codes in order to reduce the limitations previously in place:

• Code MDA 0306: only active devices for extracorporeal circulation are formally excluded
• Code MDA 0313: only active non-implantable prostheses are excluded
• Code MDA 0317: expansion to all active non-implantable devices and to devices for cleaning, disinfection, and sterilization (including moist heat and dry heat sterilizers).

This monitoring activity ensures that ECM’s scope of designation is always accurately reflected at an international level, providing operational certainty to our industrial partners.