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 | BPG for the Submission of TD under Annex II and III of IVDR/MDR | |
| 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 |