The highly anticipated institutional meeting at the Ministry of Health in Rome has successfully concluded. Ente Certificazione Macchine, represented by Technical Manager Vanessa Biavati, actively contributed to the technical roundtable regarding the challenges of the MDR Regulation and the digital evolution of the sector.

2025 MONITORING AND DIGITALIZATION

During the session, the 2025 monitoring results were presented, featuring a detailed analysis of the most frequent non-conformities identified during surveillance activities. This moment of institutional transparency is essential for raising the overall quality of national production

Significant focus was placed on digital transformation, featuring strategic updates on:

UDI System: enhancing unique device identification for full traceability;

EUDAMED: the state of the art of the European database.

ECM’S COMMITMENT TO ITS CLIENTS

Participation in this meeting is not merely an institutional duty, but a guarantee of quality for all ECM partners. Being updated ‘at the source’ on the latest ministerial directives allows us to support manufacturers with precise and timely technical consultancy, reducing uncertainties throughout the certification process.