PRRC Services

Sterling Medical Registration provides outsourced Person Responsible for Regulatory Compliance (PRRC) services, supporting your organization in meeting the mandatory requirements outlined in the EU MDR (2017/745) and IVDR (2017/746). Our PRRC professionals bring extensive regulatory expertise to ensure that your quality, safety, and compliance obligations are continuously met.

Our PRRC experts support your organization by:

Qualified Personnel: Ensuring the designated PRRC possesses the required qualifications.
Monitoring Device Conformity: Verifying that devices comply with EU MDR/IVDR requirements and meet applicable safety and performance obligations.
Technical Documentation & Declarations of Conformity: Ensuring documentation is properly maintained, updated, and supported by appropriate evidence.
Post‑Market Surveillance (PMS): Implementing, documenting, and evaluating PMS activities according to regulatory expectations.
Vigilance Oversight: Managing regulatory reporting, serious incident monitoring, trend reporting, and field safety corrective actions.
Ongoing Compliance: Supporting manufacturers, authorized representatives, and importers with quality system processes related to regulatory responsibilities.
Labeling & UDI Compliance: Reviewing and advising on labeling, UDI requirements, and market placement obligations to ensure documentation remains current and compliant.

PRRC Requirements for Importers

Under the EU Medical Devices Regulation (MDR 2017/745), importers are generally not required to appoint a Person Responsible for Regulatory Compliance (PRRC), as this obligation applies specifically to manufacturers and Authorized Representatives. However, if an importer modifies a device, changes its intended purpose, or labels it under their own name, they are considered a manufacturer under Article 16 and must appoint a PRRC.

Benefits of Outsourcing the PRRC Function

By outsourcing the PRRC role, companies gain continuous regulatory oversight without the need to hire full‑time internal staff, while maintaining full compliance with Article 15 requirements. This service provides stability, expertise, and peace of mind-ensuring that your regulatory responsibilities are fulfilled by qualified professionals dedicated to safeguarding compliance across the product lifecycle.