Registration Fees & Deadlines
300 € for SMEs and Notified Bodies members
500 € 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 – 10.15 | BPG on Technical Documentation MDR / IVDR – version 2026 | |
| Alessandro Nicoletti, Entercerma | ||
| Christine Quinton, Afnor | ||
| 10.15 – 10.45 | DIGItalisation of the Conformity Assessment Process | |
| Peter Kramar, SIQ | ||
| Marta Carnielli, TÜV SÜD | ||
| Valérie Dumay, GMED | ||
| 10.45 – 11.00 | Break | |
| 11.00 – 11.30 | EUDAMED – feedback on 1st mandatory use | |
| Natascha Jezyschek, Dekra NL | ||
| Katja Mierisch, TÜV Rheinland | ||
| 11.30 – 12.00 | Breakthrough Devices Pilot | |
| Nada Alkhayat, European Commission | ||
| 12:00 – 13:30 | Lunch | |
| 13.30 – 13.45 | Welcome | |
| 13.45 – 14.15 | Regulatory revisions – state of play | |
| Flora Giorgio, European Commission, Head of Unit DG SANTE D3 Medical Devices | ||
| 14.15 – 14.45 | NBs perspective on the revision | |
| Alexey Shiryaev – Team-NB President – DNV | ||
| 14.45 – 15.30 | Panel (EC + NBs) | |
| Anja Richter, EUROM | ||
| Oliver Bisazza, MedTech Europe | ||
| Suzanne Halliday, BSI | ||
| 15.30 – 15.45 | Break | |
| 15.45 – 16.15 | Artificial Intelligence Act & MDR | |
| Volker Sudmann, MDC | ||
| Dhananjay Khairnar, Dekra NL | ||
| Marisa Torrini, SGS Belgium | ||
| 16.15 – 16.45 | Exchanges and closing | |
| 16.45 | Drinks |