The PRRC under EU MDR Article 15

What Article 15 of the EU MDR asks of the PRRC, and how to carry the five duties through the quality system so they are ensured, not done alone.

This course is for PRRCs, the people about to take the role, and the quality and regulatory managers who work next to them. It follows Article 15 duty by duty, with the MDCG guidance, the recent changes up to EUDAMED and the new Product Liability Directive, and a short note wherever the December 2025 proposal may change something. Each lesson is a few short slides, an explanation under each slide and a check question. The course ends with a final test and a certificate of completion with a link anyone can use to verify it.

This course is for people who serve as the person responsible for regulatory compliance (PRRC) under Article 15 of the EU MDR, or who are about to take on the role, and for the managers who appoint them. It also suits QA/RA managers who work alongside a PRRC and need to know what the role ensures and how it fits into the quality system.

Explain who must appoint a PRRC, who qualifies, and what Article 15 asks of the role. Appoint a PRRC correctly and register the PRRC's details in EUDAMED. Build the five duties into the quality system, so the PRRC ensures them without doing all the work personally. Check that release, technical documentation, the EU declaration of conformity, and UDI and labeling are under control. Make sure the post-market surveillance and vigilance obligations are met on time. Understand the PRRC's legal position, including liability, protection and working with the authorities.