Registration Fees & Deadlines
Early bocking
250 € 300 € for SMEs and Notified Bodies members
400 € 500 € for organisations
You can register until August 6th
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 |