Description
Immerse yourself in the world of product registration under MDR and IVDR! In this two-part workshop, you will learn step by step how to securely and efficiently manage actors, users, and data elements in the European data environment.
In the first part on March 12, 2026, you will receive an introduction to the basics and learn about the data dictionary as a central tool. Then prepare two practical sample data sets (a regulation and a system or procedure pack) for implementation in the second part.
The second part on March 19, 2026, will focus on the registration of regulation devices, legacy devices, and systems & procedure packs in accordance with MDR and IVDR. The combination of theory and practical exercises will give you confidence throughout the entire registration process—from data preparation to successful registration.
In order to provide you with first-hand information, we are organizing this seminar in cooperation with GS1 Austria, the official UDI allocation body in Europe.
Training requirements:
Required prior knowledge: UDI requirements in Europe
Please also ensure that by March 12, 2026, you:
- can access the EUDAMED Playground. We would be happy to send you instructions!
- Apply for test SRNs for the following roles: Manufacturer, Systems and Procedure Pack Producer,
- Ideally, you should also have two EU logins: e.g., use your professional and private email addresses.
Course language: GERMAN
Seminar contents
1. Part 12.03.2026:
- Introduction & General Information
- Actor & User Management
- Getting to know the data dictionary
→ Task for Part 2: Prepare two sample data sets using the data dictionary (1x Regulation and 1x System or Procedure Pack)
2. Part 19.03.2026:
- Registration of Regulation Devices (MDR & IVDR)
- Registration of Legacy Devices
- Registration of Systems & Procedure Packs
These topics will not be covered in the workshop: M2M und XML-Upload.
Dates
This seminar takes place over 2 mornings:
- 1. Part: 12.03.2026: 09:00-12:30
- 2. Part: 19.03.2026: 09:00-12:30
Your trainer
- Poppy Abeto Kiesse, MSc, Business Development Manager Healthcare at GS 1 Austria GmbH
Costs
- Early booking (up to 4 weeks before the seminar): Euro 540,- (excl. VAT)
- Standard (from 4 weeks before the seminar): Euro 610,- (excl. VAT)
- incl. seminar documents as PDF and confirmation of participation
- All seminar discounts at a glance
