team-nb

Team-NB 1st EU Regulations Discussion Day 2025
2025-11-07 09:00 - 17:30 (Europe/Paris) | Sofitel Brussels Europe, Place Jourdan, 1, Brussels, 1040, Belgium
Registration Fees & Deadlines
250 € for SMEs and Notified Bodies members
400 € for organisations
You can register until October 28th

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 – 10.30

BPG on Technical Documentation MDR / IVDR

Jayanth Katta, BSI

Alessandro Nicoletti, Entercerma

Christoph Ziskoven, TÜV Rheinland

10.30 – 11.15

CAP (Conformity Assessment Process) Harmonistation

Marta Carnielli, TÜV SÜD

Virginie Siloret, SGS Belgium

Béatrice Lys, GMED

11.15 – 12.15

EUDAMED information – state of play by Commission

Pierre-Francois Ryelandt, European Commission

Silvia Ostuni, European Commission

12:15 – 13:45

Lunch

13.45 – 14.00

Welcome

14.00 – 14.15

Introduction on the status of the regulatory revisions

Flora Giorgio, European Commission, Head of Unit DG SANTE D3 Medical Devices

14.15 – 14.30

NBs perspective on the revision

Alexey Shiryaev, – Team-NB President – DNV

14.30 – 15.15

Panel

Oliver Bisazza, Medtech Europe

Oliver Böhle, EUROM

Ágnes Horváth, CECERTISO

Sabina Hoekstra, Team-NB Vice-President- TÜV SÜD

15.15 – 15.30

Break

15.30 – 16.15

Artificial Intelligence

Sebastian Fischer, TÜV SÜD

George Dafoulas, EKAPTY

Anni Koubek, QMD Services

16.15 – 16.30

Exchanges and closing

16.30

Drinks

MDR Clinical Training for Manufacturers
2025-08-27 13:30 - 17:30, 2025-05-07 08:30 - 12:30

MDR PMS Training
2025-07-09 09:00 - 17:00

IVDR TD Training for Manufacturers
2025-07-03 09:00 - 17:00

MDR Software Training
2025-06-18 09:00 - 17:00

MDR TD Training for Manufacturers
2025-06-17 09:00 - 17:00

MDR Clinical Data Training
2025-05-27 09:00 - 17:30

Substance-Based Devices Training
2025-03-11 09:00 - 17:00
