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

The conference will take place at the Steigenberger Graf Zeppelin hotel in Stuttgart.

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. 

 

Address: Steigenberger Graf Zeppelin hotel at Arnulf-Klett-Platz 7, 70173 Stuttgard

 

Transportation

Stuttgart city center can be reached easily from the airport by train, tram and bus.

Train connection is available to Stuttgart Central Station, which is located directly opposite of the Steigenberger Graf Zeppelin hotel. The journey between Stuttgart Central Railway Station and Stuttgart Airport takes about 27 minutes. The city train (S-Bahn) runs from Stuttgart Central Railway Station every 15 minutes. You need a ticket for 2 zones from Stuttgart Central Railway Station to the airport. More information on bus or tram connections can be found at the airport webiste.Taxi's can be found at the exit of the Arrival Terminal. 

 

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