Medical Device Regulation Law training
Gain expertise in EU MDR for orthopedic implants, covering device classification, clinical evidence requirements, supplier agreements, German liability regulations, and post-market obligations to minimise legal risks, ensure patient safety, and maintain market compliance.

4 to 360 hours of flexible workload
certificate valid in your country
What Will I Learn?
This training provides a practical overview of Medical Device Regulation (MDR) requirements, focusing on orthopedic implants and Germany. It covers device qualification, classification, clinical evidence standards, supplier and quality agreements, post-market surveillance, vigilance, and liability risks, enabling you to develop a solid compliance plan for safe market access.
Elevify Advantages
Develop Skills
- Master MDR classification for orthopedic implants with confidence.
- Plan clinical evidence including CER, PMCF, and investigations to meet MDR standards.
- Draft supplier contracts aligning quality, liability, and MDR obligations clearly.
- Set up efficient post-market surveillance, vigilance, and EUDAMED systems.
- Navigate German liability laws like ProdHaftG and BGB to manage risks.
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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