On November 6th in Brussels, a crucial event for the medical devices (MD) and in vitro diagnostics (IVD) industry will take place: the “Team-NB 2nd EU Regulations Discussion Day 2026”. Organized by Team-NB, the European Association of Notified Bodies for Medical Devices, the event promises to be a strategic forum to foster exchange and discussion among industry stakeholders, analyzing the current state and future prospects of the evolving European regulatory framework.

THE EVENT

The event aims to bring together regulators, industry representatives, and Notified Bodies for a day entirely dedicated to the implementation and optimization of the MDR and IVDR Regulations. The Discussion Day will provide an excellent platform to discuss opportunities for system optimization, while ensuring competitiveness and safety for the MedTech sector.

THE CONTRIBUTION OF ENTE CERTIFICAZIONE MACCHINE

A significant contribution to the debate will be made by Ente Certificazione Macchine (ECM), a leading Notified Body (NB 1282) in the sector. Its participation reflects the Body’s ongoing commitment to supporting regulatory dialogue and fostering the informed, shared growth of the supply chain.

In particular, Alessandro Nicoletti – Technical Expert and Lead Auditor for the Medical Devices Division at Ente Certificazione Macchine – will participate in the panel session on the analysis of annual training phases, with a strong focus on the Best Practice Guidelines (BPG) on MDR/IVDR Technical Documentation, which serve as essential guidelines to standardize the documentation required for compliance.