Person Responsible for Regulatory Compliance (PRRC)

It is required in Article 15 in both MDR and IVDR that manufacturers have a Person Responsible for Regulatory Compliance (PRRC) allocated. The PRRC shall be permanently and continuously at their disposal.

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.

For micro and small size companies, QAdvis can act as PRRC on behalf of the manufacturer. We are a team of highly competent and experienced quality and regulatory professionals, one consultant will be assigned the role, but with requirements of being continuously available, the team is prepared to step in when needed and in cases of urgency.

QAdvis consultants all have vast experiences from working with technical documentation and quality management systems for medical devices and IVDs, and they all meet and exceeds the requirements on previous experience from working in the field. QAdvis also have an internal certification process for PRRC to ensure high quality and understanding for the role.

If you already have a PRRC identified within the organization, we can support you with defining the role as well as training and understanding of the full range of responsibilities.

Contact me for further information
Per Sundström
Office +46 8 621 01 05 or send me an email