What is a PRRC?

Person Responsible for Regulatory Compliance (PRRC)

✿ Manufacturers shall have available within their organization at least one person responsible for regulatory compliance who possesses the requisite expertise in the field of medical devices.
✿Authorized representatives shall have atleast 1 PRRC, permanently and continuously at their disposal
✿ The requisite expertise shall be demonstrated by both by certain formal Educational qualifications and professional experience in the Regulatory Affairs or in the QMS
✿ Micro and small enterprises shall have such person permanently and continuously at their disposal.

Who Can Be a PRRC ?

Qualifications of a PRRC

✿(a) a diploma, certificate or other evidence of formal qualification, awarded on completion of a university degree or of a course of study recognized as equivalent by the Member State concerned, in law, medicine, pharmacy, engineering or another relevant scientific discipline, and at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices;
✿(b) four years of professional experience in regulatory affairs or in quality management systems relating to medical devices.

What are the Responsibilities of a PRRC?

Roles & Responsibilities of a PRRC

✿ Checking the conformity of devices against the QMS and controls before they are released.
✿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
✿Complying the reporting obligations and investigating vigilance issues.
✿ It is also required that the PRRC has the responsibility for regulatory compliance for devices on the market, in clinical trials and clinical performance studies.

How Trinetra can help you through PRRC Partnership

PRRC Partnership with Trinetra

✿For micro and small size companies, Trinetra can provide a PRRC.
✿Trinetra has a highly competent and experienced quality and regulatory professional.
✿Otherwise, If you already have a single or multiple PRRC identified within the organization, we can support you with
✿ Defining the role Updating your QMS
✿ Training and understanding of the full range of responsibilities
✿ The PRRC is a critical function and plays an important role in the compliance of the organization
✿It is important that senior management understands the full scope and responsibilities of the PRRC’s role, and gives them the necessary authority and cooperation to resolve any nonconformities that arise