EU MDR responsible person training
Gain mastery in EU MDR Article 15 and the PRRC role. Learn to review technical documentation, handle audits, manage risks and clinical evidence, and lead post-market surveillance and vigilance to keep your Class IIb and Class I devices safe, compliant, and ready for the market.

flexible workload from 4 to 360h
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 compliance and support safe devices.
Elevify advantages
Develop skills
- Apply Article 15 MDR requirements by defining PRRC duties, qualifications, and making daily decisions.
- Build compliant MDR technical files and confidently sign off on device releases.
- Lead Notified Body audits and respond effectively to findings using strong CAPA evidence.
- Manage MDR risks, design changes, and clinical evidence for Class IIb devices.
- Oversee post-market surveillance, vigilance reporting, and PRRC governance to protect patients and reduce liability.
Suggested summary
Before starting, you can change the chapters and 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 several topics I'm interested in without having to switch platforms... I appreciate everything you do, I've already recommended you to others...

Giulio CarloDigital Marketing Student
I like how the lessons are 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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