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ViewAttendees 8

Preconference Workshop

Devices

UDI / EUDAMED Workshop

Wednesday, May 10, 2023
08:30 – 16:00 CEST
Location: Coral (1st fl)
Description: All manufacturers of medical devices are faced with the requirements to register themselves and their products in EUDAMED, a Europe-wide database where public information about medical devices is made available to all its citizens. In order to register medical devices and provide relevant information to the public (such as vigilance reports and clinical investigations), they need a unique identifier. Therefore, the Unique Device Identification (UDI) system has been implemented in European Regulation (EU) 2017/745 (MDR) and 2017/746 (IVDR).
There are many questions about UDI and EUDAMED, fueled by new terms and expectations. In this workshop, you will learn about UDI and various modules of EUDAMED. We will create a (GS1) UDI carrier for a device label, register it in (the playground version of) EUDAMED and write a vigilance report. Furthermore, you will learn about what EUDAMED can be used for in the future - by informing you about the clinical investigation module and machine-2-machine communication between manufacturers and EUDAMED.

Tip: This is a hands-on workshop. If you bring your laptop and an example of your medical device label, you will learn how to create a GS1-compliant UDI carrier for your device. If you have (or create a personal account) at EUDAMED, you will also learn how to register the device in the EUDAMED playground environment as well as how to make a vigilance report (you don't need to register your company in the playground environment).

Agenda:
08:30 – 10:00 Workshop Session Block 1: Creating a Medical Device Label with a UDI carrier
10:00 – 10:30 Coffee break
10:30 – 11:00 Workshop Session Block 2: Actor registration (presentation only)
11:00 – 12:00 Registering a device in EUDAMED
12:00 – 13:00 Lunch
13:00 – 14:00 Workshop Session Block 3: Vigilance reporting in EUDAMED
14:00 – 14:30 Clinical investigations in EUDAMED
14:30 – 15:00 Coffee break
15:00 – 15:30 Workshop Session Block 4: M2M interface
15:00 – 16:00 Q&A UDI & EUDAMED
16:00 End of workshop

Learning Objectives:

  • The participants will understand the background and purpose of UDI and EUDAMED.
  • The participants will be able to generate a medical device label compliant with UDI requirements.
  • The participants will gain hands-on experience with (the training environment of) EUDAMED and will be able to effectively navigate in and interact with EUDAMED.
  • The participants will be able to understand how vigilance and clinical investigation requirements in EUDAMED can be complied with.
  • The participants will be able to anticipate on future interaction with EUDAMED, such as machine-2-machine interfaces.