What is a Person Responsible for Regulatory Compliance (PRRC)?

The EU Medical Device Regulation (2017/745) and In Vitro Diagnostic Regulation (2017/746) introduced a key requirement in Article 15:

"Manufacturers shall have available within their organisation at least one person responsible for regulatory compliance who possesses the requisite expertise in the field of medical devices."

As outlined in Article 15(1) and interpreted by the MDCG Guidance 2019-7, manufacturers must appoint at least one PRRC with expertise in medical devices or in vitro diagnostic devices, depending on their product category.

This requirement applies to:

• Enterprises employing 50 or more persons, and

• Those with an annual turnover or balance sheet exceeding EUR 10 million.

For micro and small manufacturers—defined by the EU Commission Recommendation 2003/361/EC as enterprises with fewer than 50 employees and annual turnover or balance sheet totals not exceeding EUR 10 million—the PRRC must be “permanently and continuously at their disposal.” In these cases, manufacturers may appoint an external subcontractor to act as their PRRC.

The Other Consultants as Your PRRC

At The Other Consultants, we provide expert PRRC services tailored to meet the needs of medical device manufacturers of all sizes. Whether you’re a large organisation or a small enterprise, we ensure you stay compliant with EU regulatory requirements, enabling you to focus on your core business operations.

Services We Provide

1. PRRC Appointment & Support

• Assisting in the appointment of a qualified Person Responsible for Regulatory Compliance (PRRC).

• Offering external PRRC services for micro and small enterprises to provide cost-effective compliance solutions.

2. Product Conformity Assurance

• Overseeing product conformity assessments to ensure compliance with your quality management system before market release.

• Conducting thorough checks to maintain the highest standards of product safety and quality.

3. Technical Documentation Management

• Checking technical documentation and EU declarations of conformity is available to meet regulatory standards.

• Providing guidance on best practices for documentation throughout the product lifecycle.

4. Post-Market Surveillance & Vigilance

• Checking the robustness of the post-market surveillance programmes to monitor device performance.

• Ensuring accurate and timely vigilance reporting systems are established to remain compliant with EU regulations.

5. Regulatory Compliance Training

• Offering tailored training programmes to help your team understand and implement regulatory and quality management requirements.

• Providing regular updates on changes to EU regulations to ensure your organisation remains informed and compliant.

Why Choose The Other Consultants?

• Extensive Expertise: Our team has years of experience in regulatory affairs and quality management systems, specifically for medical devices.

• Customised Solutions: We adapt our services to meet the unique needs of your organisation, ensuring effective compliance strategies.

• Commitment to Excellence: We are dedicated to supporting your success by helping you achieve and maintain regulatory compliance.

Partner with The Other Consultants and navigate the complexities of regulatory compliance with confidence.