Description
This seminar will be held in German!
In addition to the various labeling requirements, the EU regulations for medical devices (MDR) and IVDs (IVDR) also apply. With these regulations, the introduction and implementation of unique device identification (UDI) for medical devices is also mandatory in the EU.
This seminar gives you an overview of how you can best implement UDI labeling and which requirements you need to meet for packaging (e.g. labels), device (e.g. symbols, labels), instructions (e.g. instructions for use) and enclosed material (e.g. brochures).
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.
Seminar contents
- MDR-IVDR: Requirements for UDI:
– Overview of UDI
– UDI interfaces (quality management, production, other business processes)
– UDI as part of EUDAMED - Labelling – Requirements for packaging, device, instructions and accompanying material
– ISO 15223-1:2017 Symbols to be used on medical device labels, marking and information to be provided
– EN ISO 20417:2021 Medical devices – Requirements for information to be provided by the manufacturer
– Language requirements for labeling - Steps for the successful implementation of UDI
– UDI issuing rules
– UDI labeling rules
– Barcode quality
– Barcode verification
– Master data management
– Master data exchange
This seminar is part of our online course: Regulatory Specialist for Medical Devices and IVD.
Date
This seminar takes place over 2 mornings:
- 1st part: 26.11.2025 from 09:00-12:00 with Ms. Poppy Abeto Kiesse, MSc
- 2nd part: 05.12.2025 from 09:00-12:30 with both trainers
Participants
Basic knowledge of the MDR and IVDR is recommended.
Your trainers
- DI Martin Schmid, Managing Director & Senior Consultant at en.co.tec Schmid KG
- 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 certificate of participation
- All seminar discounts at a glance
