The medical device sector is currently undergoing a phase of profound regulatory and technological transformation. In this context, direct dialogue between competent authorities and Notified Bodies is essential to ensuring a safe and competitive market. On March 4, 2026, Ente Certificazione Macchine (ECM) will participate in the important meeting convened by the Ministry of Health at its headquarters in Viale G. Ribotta, Rome.

ECM’s PARTICIPATION

Representing ECM at this prestigious technical committee will be our Technical Manager, Vanessa Biavati. Her participation highlights the organization’s commitment to solidifying its position as an authoritative partner within the certification landscape.

“Being present at these institutional committees allows us to incorporate ministerial interpretations in real time and to bring our operational experience directly to the heart of the regulatory debate,” Biavati stated ahead of the meeting.

THE TECHNICAL COMMITTEE AGENDA: FOCUS ON MDR AND SURVEILLANCE

The meeting agenda reflects the most current challenges for manufacturers and certification bodies. Key points of the discussion include:

• Updates on Regulation (EU) 2017/745 (MDR): Analysis of proposed amendments and changes to Annex VII requirements, which are essential for maintaining the notification status of bodies.

• 2025 Monitoring Results: A session dedicated to analyzing the most recurring non-conformities identified during surveillance activities, with the aim of continuously raising safety standards.

DIGITAL TRANSFORMATION

“Significant space will be dedicated to the evolution of digital systems, with specific updates on the European database EUDAMED and the Unique Device Identification (UDI) system.”

ECM’S COMMITMENT TO ITS CLIENTS

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

In the coming weeks, ECM’s official channels will provide further insights into the meeting’s outcomes, continuing the essential informative work needed to navigate the complex international regulatory landscape.