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Practical Information

 

Participation

The EUDAMED Workshop is to be held in hybrid mode, allowing for both physical and remote participation.

  • Online participants will receive connection details by email one day before the event.

  • Physical participants are welcome at the venue from 08:45 onwards for registration.

 

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

 

Venue

BRUSSELS

Hilton Brussels Grand Place
Carrefour de l’Europe 3, 1000 Brussels, Belgium
Google Maps link
Website of the hotel

A registration desk will be open from 8:45. Upon arrival, you will receive your badge and be kindly asked to sign an attendance list. The event will officially start at 9:30. 

 

Working languages

The working language of the workshop will be English.

 

Cancellation and no-show policy

If you need to cancel your participation, please inform us as soon as possible by sending an email to eudamed-events@cecoforma.com. This allows us to offer your place to another participant.

 

Kind regards,

Organising Team
eudamed-events@cecoforma.com