2nd Team-NB EU Regulations Discussion Day 2026
2026-11-06 09:00 - 17:00 (Europe/Paris) | Sofitel Brussels Europe, Place Jourdan, 1, Brussels, 1040, Belgium
Registration Fees & Deadlines
Early boocking
250 € 300 € for SMEs and Notified Bodies members
400 € 500 € for organisations
You can register until August 6th
REGISTRATION

Event Summary
This event aims to foster exchanges between stakeholders in the medical device sector.
Three topics of topical matters have been chosen for their relevance to the implementation of the regulatory system.
Team-NB task forces on those matters will present Papers and ongoing work. Members present will answer questions and take note of developments requested by manufacturers.
An information session on EUDAMED will be presented by Commission experts. It will also be followed by discussions.
Finally, Team-NB’s views on the revision outlook will be presented, and a panel of regulators, industry representatives, and notified bodies will answer participants’ questions.
This day will provide an excellent forum for exchanges between regulators, industry representatives, and notified bodies on opportunities for optimizing and modifying the system.

PROGRAM

09.00 – 09.30

Welcome coffee

09.30 – 09.45

Welcome and Introduction

Françoise Schlemmer – Team-NB Director

09.45 – 10.15

BPG on Technical Documentation MDR / IVDR – version 2026

10.15 – 10.45

DIGItalisation of the Conformity Assessment Process

10.45 – 11.00

Break

11.00 – 11.30

EUDAMED – feedback on 1st mandatory use

11.30 – 12.00

Breakthrough Devices Pilot

12:00 – 13:30

Lunch

13.30 – 13.45

Welcome

13.45 – 14.15

Regulatory revisions – state of play

14.15 – 14.45

NBs perspective on the revision

14.45 – 15.30

Panel

15.30 – 15.45

Break

15.45 – 16.15

Artificial Intelligence Act & MDR

16.15 – 16.45

Exchanges and closing

16.45

Drinks
