UDI/MDR training
This course provides comprehensive training on EU-MDR labelling and UDI requirements for complex medical devices like reusable Bluetooth-enabled infusion pumps. Participants will learn legal obligations, risk classification, mandatory label and packaging content, IFU and electronic instructions rules, usability and risk management, plus UDI/EUDAMED data workflows to ensure documentation is fully compliant, traceable, and ready for inspections. Devices will remain safe and compliant for patients and clinicians.

from 4 to 360h flexible workload
valid certificate in your country
What will I learn?
Gain practical knowledge on EU-MDR labelling and UDI for complex devices such as reusable Bluetooth infusion pumps. Cover legal requirements, risk classification, essential label and packaging elements, IFU and e-information standards, usability controls, risk mitigation, and UDI/EUDAMED data processes for compliant, traceable, 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 IFUs and e-IFUs that meet Annex I requirements.
- Design risk-based labels with warnings, symbols, and IFU content to prevent misuse.
- Ensure compliance for Bluetooth devices in 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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