Person Responsible for Regulatory Compliance (PRRC)

Person Responsible for Regulatory Compliance (PRRC) is a new role introduced in MDR and IVDR and is required for all medical and IVD device manufacturers to have this person identified and allocated.

The PRRC has the responsibility for regulatory compliance for devices on the market, in clinical trials and clinical performance studies. This is conducted by ensuring that the technical documentation and declaration of conformity is drawn up and kept up to date, fulfilling the obligations related to post market surveillance as well as reporting and investigating vigilance issues. It is also required that the PRRC controls the conformity of devices before they are released to the market.

Learn how a PRRC could be introduced into you organization and interpret the requirements for your devices. During the course, the following topics will be covered

Topics

• Article 15
• PRRC qualifications
• External or internal PRRC
• Responsibilities and authorities
• Legal aspects
• Available guidelines

Target group
Medical device manufacturers, management and QA/RA professionals. Prior experience of MDR/IVDR and ISO 13485 is required.

Course presentations
Course material will be in English, verbal presentation and discussions in English.

Course leader
Emma Axelsson, Senior Quality and Regulatory Consultant