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.
Registration Fees & Deadlines
250 € for SMEs and Notified Bodies members
400€ for organisations
You can register until October 28th.
Agenda
09.00 – 09.30 Welcome coffee
09.30 – 09.45 Welcome and introduction
09.45 – 10.30 BPG on Technical Documentation MDR / IVDR
10.30 – 11.15 BPG for the Submission of TD under Annex II and III of MDR (V3)
11.15 – 12.15 EUDAMED information – state of play by Commission
12:15 – 13:45 Lunch
13.45 – 14.00 Welcome and introduction
14.00 – 14.20 NBs perspective on the revision
14.20 – 15.00 Panel
15.00 – 15.15 Break
15.15 – 16.00 Artificial Intelligence
16.00 – 16.30 Exchanges and closing
16.30 – Drinks