UDI/MDR training
Gain mastery in EU-MDR and UDI requirements for medical devices in healthcare settings. Acquire knowledge on labelling standards, risk assessment, IFU development, UDI/EUDAMED data handling, and post-market surveillance to ensure ongoing compliance, traceability, and safety for patients and healthcare professionals.

flexible workload of 4 to 360h
valid certificate in your country
What will I learn?
UDI/MDR Training offers a targeted, hands-on approach to EU-MDR labelling and UDI for sophisticated devices like reusable Bluetooth infusion pumps. Discover regulatory obligations, risk categorisation, essential label and packaging details, IFU and digital info guidelines, usability safeguards, risk mitigation strategies, along with UDI/EUDAMED data processes and workflows to make your documents fully compliant, trackable, and prepared for audits.
Elevify advantages
Develop skills
- EU-MDR labelling expertise: implement Annex I, II, III guidelines on actual device labels.
- UDI and EUDAMED proficiency: prepare compliant UDI-DI/PI information and register devices efficiently.
- IFU and e-IFU creation: develop precise, localised, Annex I-compliant user instructions.
- Risk-oriented labelling: craft warnings, symbols, and IFU details to prevent misuse.
- Bluetooth device adherence: synchronise software, connectivity, and cybersecurity labelling requirements.
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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