The Role of the Person Responsible for Regulatory Compliance (PRRC) Under MDR and IVDR Training Course

This training course aims to provide a comprehensive understanding of the Person Responsible for Regulatory Compliance (PRRC) role under the Medical Device Regulation (MDR) and In-Vitro Diagnostic Regulation (IVDR). The course covers the role's responsibilities, integration into the Quality Management System, and the UK MDR Qualified Person role. Participants will gain insights and practical strategies to ensure compliance and regulatory success. The course is ideal for quality managers, regulatory affairs professionals, start-up organizations, compliance engineers, and medical device manufacturers.

The Person Responsible for Regulatory Compliance (PRRC) role, mandated under the Medical Device Regulation (MDR) 2017/745 and the In-Vitro Diagnostic Device Regulation (IVDR) 2017/746, has become a critical component for medical device and in-vitro diagnostic (IVD) manufacturers. This role ensures that organizations comply with the stringent regulatory requirements set forth by these regulations. A new training course, "The Role of the Person Responsible for Regulatory Compliance (PRRC) Under the MDR and IVDR Training Course," aims to equip professionals with the necessary knowledge and tools to effectively implement the PRRC role within their organizations.

The course, available online on September 22, 2025, is designed to provide a comprehensive understanding of the PRRC role, its responsibilities, and how it integrates into the Quality Management System (QMS). Participants will gain insights into Article 15 of the regulations, which outlines the specific requirements for the PRRC role. The course will also cover the UK MDR requirements and the proposed Qualified Person (QP) role, providing a comparative analysis of these roles. Additionally, the course will delve into the provision of PRRC services by third parties, addressing how organizations can meet all requirements remotely.

The training course is ideal for quality managers, regulatory affairs professionals, start-up organizations, compliance engineers, and medical device manufacturers. It offers a CPD certification of 6 hours and a certificate of completion upon successful completion. The course agenda includes topics such as the origins of the PRRC/UK QP role, the gap it addresses, and the specific requirements outlined in Article 15. Practical applications and real-world examples will be used to illustrate the integration of the PRRC role into the QMS.

The course is an excellent opportunity for professionals to understand the significance of the PRRC role and its critical place in their organizations. It equips participants with the insights and practical strategies needed to ensure compliance and regulatory success. The course is available for more information at [ResearchAndMarkets.com](https://www.researchandmarkets.com/r/hxmfzd).

References:
[1] https://www.businesswire.com/news/home/20250804640516/en/The-Role-of-the-Person-Responsible-for-Regulatory-Compliance-PRRC-Under-the-MDR-Medical-Device-Regulation-and-IVDR-In-Vitro-Diagnostic-Regulation-Training-Course-ONLINE-September-22-2025---ResearchAndMarkets.com
[2] https://simplerqms.com/ce-marking-for-medical-devices/