La Comisión Europea ha organizado estas jornadas para facilitar la puesta en marcha de EUDAMED y esta es la primera después de la publicación del aviso de
puesta en marcha de EUDAMED
Timing
- 08:45 – 09:30 Registrations (only for physical participants)
- 09:30 – 11:00 Session 1
- 11:00 – 11:15 Coffee Break
- 11:15 – 12:15 Session 2
- 12:15 – 13:45 Lunch Break
- 13:45 – 15:00 Session 3
- 15:00 – 15:15 Coffee Break
- 15:15 – 16:45 Session 4
- 16:45 – 17:00 Break (no coffee)
- 17:00 – 17:45 Session 5
- 17:45 – 18:45 Networking Drink (only for physical participants)
Content
Session 1
- Introduction on MDR/IVDR
- EUDAMED legal basis, obligations, and purposes
- Timeline and plan for gradual roll-out
- EUDAMED structure (6 integrated modules) and available environments
- Available information sources (websites, Information Centres, Guidance documents – with a focus on the last one on gradual roll out)
Session 2:
- EUDAMED functionalities overview
- Actors Module: purposes, scope, functionalities, and main business rules per actor role
Session 3:
- UDI/Devices Module: purposes, scope, functionalities, and main business rules per type of device
Session 4:
- NBs & Certificates Module: purposes, scope, functionalities, main business rules for certificates, and linkage with devices
Session 5:
- Market Surveillance Module: purposes, scope, and main business rules for procedures