PRRC – Person Responsible for Regulatory Compliance
In the current regulatory environment, compliance is essential for Medical Device and IVD manufacturers.
In the EU, these manufacturers are required to appoint a Person Responsible for Regulatory Compliance (PRRC) in line with Article 15 of MDR 2017/745 and IVDR 2017/746.
The position requires specific qualifications related to training and experience and involves personal responsibility. The PRRC ensures the safety, quality, and effectiveness of medical devices and software. Mandated by EU regulations, a PRRC must be designated by manufacturers and authorized representatives operating within the EU.
External PRRC for small enterprises
EU regulations allow micro and small enterprises (under 50 employees and with limited turnover) to meet PRRC requirements by having access to an external consultant or third-party provider, instead of hiring an in-house specialist. This approach enables small manufacturers to stay compliant while managing resources efficiently.
Mandatory qualifications
To qualify as a PRRC, an individual must have a relevant university degree—such as in law, medicine, pharmacy, engineering, or a scientific discipline—and at least one year of experience in regulatory affairs or quality management for medical devices or IVDs. Alternatively, a candidate without the required educational background may qualify by having four years of professional experience in regulatory affairs or quality management systems related to medical devices.
Duties
The PRRC ensures that medical devices and IVDs comply with all regulatory requirements throughout their lifecycle. Key duties include verifying device conformity checks per company QMS, maintaining essential documents like technical files and EU declarations of conformity, and managing post-market surveillance. The PRRC also oversees regulatory reporting and confirms proper statements for investigational devices per EU law. This role supports product safety, quality, and compliance in the EU market, especially benefiting SMEs lacking in-house regulatory staff.
It is necessary to clearly define the PRRC’s authority within the organization’s Quality Management System (QMS), which includes decision-making capabilities and the power to halt production if compliance risks are detected.
GBA Key2Compliance offer PRRC services specifically designed for organizations with fewer than 50 employees. These services are structured to ensure that PRRCs fulfill all regulatory obligations while upholding patient safety and compliance standards.
GBA Key2Compliance PRRC Service
For manufacturers with fewer than 50 employees, GBA Key2Compliance can directly assume the PRRC role in compliance with Article 15 of MDR 2017/745 and IVDR 2017/746.
This includes providing qualified personnel who meet all regulatory requirements and ensuring the company’s full commitment to patient safety and regulatory obligations.
The process begins with a start-up meeting to clarify expectations and facilitate access to essential documentation, such as the technical file and QMS. GBA Key2Compliance conducts thorough gap analyses of both the technical documentation and quality management system, highlighting areas for improvement and collaborating with the manufacturer to address regulatory requirements. Their team also takes responsibility for ongoing quarterly reviews, monitoring non-conformities, CAPA, customer complaints, vigilance, post-market surveillance, product releases, and the validity of the EU declaration of conformity.
Furthermore, GBA Key2Compliance provides responsive support for vigilance cases and major change notifications, ensuring that any issues are promptly addressed with full cooperation between the manufacturer and PRRC. This comprehensive approach allows companies to focus on their core business while safeguarding regulatory integrity and patient safety through expert PRRC support.
We offer the following benefits
- Confidence in compliance
- Reduced regulatory burden
- Enhanced patient safety and product quality
- A proactive partner in your regulatory journey
GBA Key2Compliance offers comprehensive support tailored for organizations seeking PRRC services. This includes providing qualified personnel who meet all regulatory requirements and ensuring the company’s full commitment to patient safety and regulatory obligations.
Get in Touch
Ready to ensure compliance and protect your business?
Contact us today to discover how our expert PRRC services can help you stay compliant, give you confidence, reduce your regulatory burden, and help you achieve ongoing success in the medical device industry.