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
Speakers
Stuart Angell,
Director ,
IVDeology LtdStuart Angell, This MDTI expert is a joint director in his own consultancy specialising in global regulatory affairs strategy and compliance for in vitro diagnostics and medical devices focusing on the transition to the new IVD/Medical Device Regulations, MDSAP and ISO13485:2016.
He has over 15 years in the IVD industry and in previous roles has been responsible for designing, reviewing and maintaining regulatory frameworks for self-declared and annex list II products including technical documentation for EU and global submissions (FDA, Health Canada, TGA, Russia, Latin America). He has an excellent understanding of risk management, Post Market Surveillance (PMS) and vigilance.
Who Should Attend
This course is ideal for those seeking to understand the role of the Person Responsible for Regulatory Compliance (PRRC), and those currently holding or considering the PRRC designation within medical device companies, including:
- Quality managers/specialists
- Regulatory affairs professionals
- Start-up organisations with a need to understand where the PRRC role is required
- Compliance engineers
- Medical device manufacturers
- Those considering undertaking the PRRC role
