PRRC Services

Person Responsible for Regulatory Compliance (PRRC)

Ensuring MDR Compliance with Expertise

Under MDR Article 15, all medical device manufacturers and certain EU importers must appoint a Person Responsible for Regulatory Compliance (PRRC) to oversee compliance with MDR requirements. This is not just a regulatory obligation—it’s a critical role in ensuring the safety, quality, and compliance of your products in the European market.

As your PRRC, we take on this responsibility with deep regulatory expertise and hands-on industry experience. We ensure that your quality management system (QMS), technical documentation, and post-market surveillance activities fully comply with MDR. Our approach is proactive, helping you avoid compliance risks before they become costly problems.

Why Is the PRRC Role Important?

The PRRC is responsible for:

Mandated by EU Regulations – The EU Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR) mandate that manufacturers and authorized representatives have a PRRC
Internal Audits (ISO 13485 & MDR) – Verifying that devices meet regulatory and QMS requirements before release.
Maintaining Technical Documentation – Keeping records up to date and audit-ready.
Post-Market Surveillance (PMS) & Vigilance –Overseeing incident reporting and ensuring compliance with safety measures.
Regulatory Oversight of Device Compliance – Ensuring that your medical devices adhere to the required regulations at every stage, from design to post-market activities.

Importance of the PRRC:

Safety and Quality – The PRRC plays a vital role in ensuring the safety, integrity, quality, and effectiveness of medical devices.
Compliance Enforcement – The PRRC has the power to ensure that the company meets all relevant quality regulations and standards, including initiating actions to rectify non-compliance.
Penalties for Non-Compliance – Failure to appoint a PRRC or for the PRRC to fulfill their duties can result in significant penalties, including fines and even imprisonment in some member states.

What Qualifications Are Required for a PRRC?

MDR Article 15 requires the PRRC to have:

Key Responsibilities:

The PRRC is responsible for:

Conformity Checks: The PRRC ensures that devices meet the essential safety and performance requirements before they are released.
Documentation Management: They are responsible for maintaining up-to-date technical documentation and EU declarations of conformity.
Post-Market Surveillance: The PRRC ensures that post-market surveillance obligations are complied with, including vigilance reporting.
Reporting Obligations: They ensure that the company meets all reporting obligations to authorities or notified bodies.

Key Responsibilities of the PRRC (as per MDR Article 15):

The PRRC is responsible for:

Verification of Conformity – Ensuring that the products conform to the MDR requirements before being placed on the market or put into service.
Monitoring QMS Compliance – Overseeing that the Quality Management System (QMS) complies with MDR and ensuring proper maintenance.
Managing Technical Documentation – Ensuring that all necessary documentation is completed and readily available for inspection by authorities.
Ensuring Post-Market Surveillance – Coordinating the ongoing surveillance of products once they’re on the market, ensuring compliance with reporting requirements for incidents, field safety notices, and corrective actions.

PRRC Services

Person Responsible for Regulatory Compliance (PRRC)

Why Is the PRRC Role Important?

Importance of the PRRC:

What Qualifications Are Required for a PRRC?

Key Responsibilities:

Key Responsibilities of the PRRC (as per MDR Article 15):

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