EU MDR responsible person training
Master EU MDR Article 15 and the PRRC role. Gain skills to review technical documentation, manage audits, oversee risk and clinical evidence, and lead post-market surveillance and vigilance, ensuring Class IIb and Class I devices remain safe, compliant, and market-ready. This training equips you to perform PRRC duties confidently while safeguarding compliance.

4 to 360 hours flexible workload
valid certificate in your country
What will I learn?
EU MDR Responsible Person Training provides clear, practical guidance to perform PRRC duties confidently. Master Article 15 requirements, technical documentation, device release controls, risk management, clinical evidence, post-market surveillance, audits, vigilance reporting, change control, and governance to ensure safe, compliant devices.
Elevify advantages
Develop skills
- Apply Article 15 MDR: define PRRC duties, qualifications, and daily decisions.
- Build compliant MDR technical files and sign device release with confidence.
- Lead Notified Body audits and respond to findings with robust CAPA evidence.
- Manage MDR risk, design changes, and clinical evidence for Class IIb devices.
- Oversee PMS, vigilance, and PRRC governance to protect patients and liability.
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
Your classes are perfect. I got the one-year package and finally have the chance to follow a range of topics I'm interested in without having to switch platforms... thank you for everything you do, I've already recommended you to others...

Giulio CarloDigital Marketing Student
I like how the lessons get straight to the point and how I can switch chapters and skip content I don't need.

Mariana FerresPhotography Student
I like the content and the way the videos are presented and transcribed, which speeds up the process!

Luciana AlvarengaNail Design Student
The platform is fast and easy to use. The variety of content and the extra videos really help with learning.

Giulio CarloPrompt Engineering Student
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