Tomorrow Brussels will host an event of crucial importance for the medical devices (MD) and in vitro diagnostics (IVD) industry: the “Team-NB 1st EU Regulations Discussion Day 2025”. Organized by the European Association of Notified Bodies for Medical Devices (Team-NB), the event is set to be a strategic forum to foster exchange and discussion among sector stakeholders, analyzing the current state and future prospects of the complex European regulatory system.

THE EVENT AND KEY TOPICS

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 day’s agenda has been structured around highly current and fundamentally relevant topics for the supply chain:

• Best Practice Guidelines (BPG) on MDR/IVDR Technical Documentation: A focus on the essential guidelines to standardize the documentation required for compliance.
• Harmonization of the Conformity Assessment Process (CAP): Discussions aimed at unifying certification procedures among the various Notified Bodies.
• EUDAMED Information Session: Experts from the European Commission will present the state of play and future developments of the European medical device database.
• Regulatory Revision Outlook: Team-NB’s vision on the optimization and possible modification of the regulatory system will be presented.
• Artificial Intelligence (AI): A panel dedicated to the impact and regulation of AI in the context of medical devices.

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

An authoritative contribution to the debate will be provided by Ente Certificazione Macchine (ECM), a leading Notified Body (NB 1282) in the sector. Its participation testifies to the organization’s constant commitment to supporting regulatory dialogue and the conscious, shared growth of the supply chain.

In particular, Tatiana Vignudelli from Ente Certificazione Macchine will be present as the organization’s representative, bringing operational experience and the perspective of a Notified Body that works daily within the complex conformity assessment process. Her presence is anticipated in the key discussions on regulation, offering a direct viewpoint on the challenges and best practices that have emerged so far, with the goal of providing essential insights for manufacturers and for the future development of guidelines.