UDI/MDR training
Gain expertise in EU-MDR and UDI requirements for medical devices in healthcare settings. Master labelling standards, risk classification, IFU development, UDI/EUDAMED data management, and post-market surveillance to ensure devices are compliant, traceable, safe for patients, and ready for inspections.

from 4 to 360h flexible workload
valid certificate in your country
What will I learn?
This training provides practical guidance on EU-MDR labelling and UDI for complex devices like reusable Bluetooth-enabled infusion pumps. Cover legal requirements, risk classification, label and packaging content, IFU and electronic instructions, usability controls, and UDI/EUDAMED workflows for full compliance and traceability.
Elevify advantages
Develop skills
- Master EU-MDR labelling by applying Annex I, II, III rules to device labels.
- Develop UDI and EUDAMED expertise to create compliant UDI-DI/PI data and register devices.
- Learn to write clear, localised IFU and e-IFU compliant with Annex I requirements.
- Design risk-based labelling with warnings, symbols, and IFU to prevent misuse.
- Ensure compliance for Bluetooth devices in software, connectivity, and cybersecurity labelling.
Suggested summary
Before starting, you can change the chapters and workload. Choose which chapter to start with. Add or remove chapters. Increase or decrease the course workload.What our students say
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