UDI/MDR training
Gain expertise in EU-MDR and UDI requirements for medical devices in healthcare settings. Master labelling, risk classification, IFU creation, UDI/EUDAMED data management, and post-market surveillance to keep devices compliant, traceable, and safe for patients and healthcare providers.

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, essential label and packaging content, IFU and electronic instructions rules, usability and risk management, plus UDI/EUDAMED data workflows for fully compliant and inspection-ready documentation.
Elevify advantages
Develop skills
- Master EU-MDR labelling by applying Annex I, II, III rules to actual device labels.
- Develop UDI and EUDAMED expertise to create compliant UDI-DI/PI data and register devices efficiently.
- Learn to write clear, localised IFU and e-IFU that meet Annex I requirements.
- Design risk-based labels with warnings, symbols, and IFU content to prevent misuse.
- Ensure compliance for Bluetooth devices by aligning software, connectivity, and cybersecurity labelling.
Suggested summary
Before starting, you can change the chapters and the 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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