UDI/MDR training
Gain mastery in EU-MDR and UDI requirements for medical devices in healthcare settings. Acquire skills in labelling, risk classification, IFU creation, UDI/EUDAMED data management, and post-market surveillance to ensure devices remain compliant, traceable, and safe for patients and clinicians.

4 to 360 hours of flexible workload
certificate valid in your country
What Will I Learn?
UDI/MDR Training offers a targeted, practical overview of EU-MDR labelling and UDI for complex devices like reusable Bluetooth-enabled infusion pumps. Discover legal obligations, risk classification, essential label and packaging details, IFU and electronic instructions guidelines, usability and risk mitigation strategies, plus UDI/EUDAMED data handling and processes to achieve compliant, traceable, and inspection-ready documentation.
Elevify Advantages
Develop Skills
- EU-MDR labelling expertise: implement Annex I, II, III requirements on actual device labels.
- UDI and EUDAMED proficiency: construct compliant UDI-DI/PI data and register devices efficiently.
- IFU and e-IFU development: produce clear, localised, Annex I-compliant instructions.
- Risk-based labelling design: craft warnings, symbols and IFU content to minimise misuse.
- Bluetooth device compliance: ensure labelling for software, connectivity and cybersecurity aligns with regulations.
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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