[2025-09-19] (Open access) Team-NB (The European Association of Medical devices Notified Bodies) announces its 1st EU Regulations Discussion Day 2025.
This event is aimed at small and medium-sized enterprises (SMEs), members of notified bodies and organizations. It aims to encourage exchanges between stakeholders on the future European regulatory framework for the medical devices sector.
This one-day event will take place at the Sofitel Brussels Europe (Brussels), on Friday November 7, 2025, from 9:00 am to 5:30 pm.
According to the official program, the day is organized around three main themes:
- Good practices for the preparation and submission of technical documentation in accordance with regulations (EU) 2017/745 on medical devices (MDR) and (EU) 2017/746 on in vitro diagnostic medical devices (IVDR);
- EUDAMED progress report presented by European Commission experts;
- and a good part of the day will be devoted to the state of play and prospects for revising the regulations (from the viewpoints of notified bodies, regulators and industry representatives).
There will also be a special focus on artificial intelligence (AI) applied to medical devices.
The number of places available is not specified. You must
According to European Union definitions (Recommendation 2003/361/EC), micro, small and medium-sized enterprises are those employing fewer than 250 people, with annual sales not exceeding 50 million euros or whose annual balance sheet total does not exceed 43 million euros.
The European Commission has made available an online tool, “SME Self-assessment (SME Wizard)”, to help participants determine whether their organization meets the criteria to be considered a small or medium-sized enterprise.
The day provides an excellent opportunity to discuss ways of optimizing and modifying current European regulations for the medical devices sector.
Article written by Lam-Xé NOEL, Managing Director of DM Experts SAS