Presented by
Management Forum
This one day course will cover the role of the Person Responsible for Regulatory Compliance (PRRC) introduced by the implementation of the Medical Device Regulation 2017/745 and the In-Vitro Diagnostic Device Regulation 2017/746. The course will review Article 15 from the regulation in detail to enable understanding of the intent of each requirement. It will also present the UK Medical Device Regulation requirements and discuss the proposed Qualified Person role with current information.
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.
This course is of our range of Medical Devices training courses - now also including Medical Devices Cyber Security training to help improve your data security.
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:
24 Sep 2024
Nancy Consterdine is a joint director in her 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.
She has over 30 years in the IVD industry and in previous roles has been responsible for designing, reviewing and maintaining regulatory frameworks for self-declared and annex II list products. Also identifying regulatory strategies around global submissions (EU, FDA, Health Canada, TGA, Russia, Latin America and China). She has a special interest in labelling and UDI requirements.
23 Jan 2025
22 May 2025
22 Sep 2025
Stuart Angell 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.
24 Sep 2024
TszWai Woo is a regulatory specialist at IVDeology Ltd. She brings her exceptional regulatory experience from 16 years within the IVD industry to support IVD manufacturers navigate the IVD regulations including CE IVDD, CE IVDR, UKCA and ISO13485 Quality Management Systems
United Kingdom
Israel
Denmark
Germany
Poland
Multiple colleagues? See above for details of our discounts for 2, 3, or 4 delegates. For more, talk to one of our training experts to discuss how to: