PRRC (Person Responsible for Regulatory Compliance) Training
Gain mastery in PRRC duties under EU MDR/IVDR regulations. Acquire practical tools like checklists, documentation practices, vigilance protocols, and lifecycle controls to guarantee safe medical device releases, robust audit trails, and full regulatory compliance in healthcare product management.

flexible workload of 4 to 360h
valid certificate in your country
What will I learn?
This PRRC Training equips you with vital skills to confidently fulfil MDR and IVDR Article 15 requirements. Master interpreting key regulations, handling lifecycle duties, supervising clinical and performance evaluations, approving market releases, managing documentation, and addressing incidents plus FSCA to keep your organisation compliant, audit-prepared, and in line with European standards.
Elevify advantages
Develop skills
- Apply PRRC release controls with MDR/IVDR checks, sign-offs, and audit-ready records.
- Build regulatory documentation including PRRC files, templates, and traceable evidence.
- Lead risk and vigilance tasks like incident reporting, FSCA decisions, and CAPA oversight.
- Verify clinical and performance reviews using CER/PER/PMPF and state-of-the-art data.
- Embed PRRC oversight checkpoints across the full device lifecycle from design to post-market.
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 workloadWhat our students say
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