Certified Person Responsible for Regulatory Compliance (English)

The course is specialized for the PRRC (Person Responsible for Regulatory Compliance) according to Article 15 of the EU MDR.

The goal of the course is to help participants, who are likely PRRCs, understand their roles and responsibilities under the EU MDR and how to effectively fulfill them.

The course will cover the following topics:

• Requirements and how to ensure the PRRC fulfils their responsibilities
• How to work with the MDR (Medical Device Regulation)
• Obligations of the manufacturer
• PRRC-specific responsibilities
• Post-market surveillance