Attend this one-day course to gain a comprehensive understanding of the critical role of the Person Responsible for Regulatory Compliance (PRRC) introduced by the Medical Device Regulation 2017/745 and the In-Vitro Diagnostic Device Regulation 2017/746.
In the evolving landscape of medical device regulation, understanding and complying with new roles and requirements is crucial for maintaining market access and ensuring patient safety. The introduction of 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 created a pivotal position within organisations, necessitating a deep understanding of its responsibilities and integration into existing systems.
This course is designed to address these challenges and provide participants with the necessary knowledge and tools to effectively implement the PRRC role within their organisations.
This comprehensive one-day course will delve into Article 15 of the regulation in detail, ensuring a thorough understanding of each requirement's intent. Participants will also be briefed on the UK MDR requirements and the proposed Qualified Person (QP) role, based on the latest information.
A key focus will be the integration of the PRRC role into the Quality Management System, supported by real-world examples to illustrate practical applications. The course will explore the provision of PRRC services by third parties, addressing how to meet all requirements remotely from the manufacturer.
This course offers an excellent opportunity to grasp the significance of the PRRC role and its critical place in your organisation, equipping you with the insights and practical strategies to ensure compliance and regulatory success.
Benefits of Attending
- Understand the role and responsibilities of the PRRC
- Identify ways of incorporating the PRRC role into your organisation and Quality Management System
- Compare the EU PRRC role with the proposed UK MDR Qualified Person role
- Gain a clearer understanding of the PRRC role for those considering whether they should undertake this
Certifications:
- CPD: 6 hours for your records
- Certificate of completion
