Date: 24 June and 1 July 2025 (2 sessions)
Time: 14:00h - 17:00h CEST | 9am - 12pm EST
Location: Virtual
Language: English
Costs: € 1270,- / $ 1417
Introduction
The Person Responsible for Regulatory Compliance (PRRC) is a key role introduced under the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). As a PRRC, you are accountable for ensuring compliance across all aspects of the device lifecycle, including technical documentation, quality management, clinical evidence, and post-market surveillance. Given these broad responsibilities, appropriate qualifications and experience are essential.
Led by René Schings (session 1) and Robert Paassen (session 2), this training offers clear guidance on the PRRC role and its responsibilities to ensure organizational compliance. Key topics include qualifications, appointment, registration, tasks, compliance, and administrative duties. The course is intended for current or prospective PRRCs, and is equally valuable for management seeking a full understanding of the PRRC function.
A certificate is included in the price of this training and confirms your successful qualification as a PRRC. It outlines the learning objectives and verifies whether you meet the MDR/IVDR requirements for PRRC qualification (experience and background). The personalized certificate can be presented to Notified Bodies during audits.
Learning Objectives
- Understand the background of MDR/IVDR to understand PRRC requirements and where they are coming from
- What are the roles and responsibilities of PRRC
- Qualifications of PRRC
- Relation of PRRC and your QMS
- Learn how to appropriately check the conformity of the devices
- Understand what checks are proportionate to the risk class and the type of device
- How to keep the technical documentation and the EU declaration of conformity up-to-date
- Checks to fulfill for post-market surveillance obligations
- Reporting obligations for recording and reporting of incidents and field safety corrective actions
- What to do as PRRC if there are devices undergoing clinical investigation (MDR) or performance studies (IVDR)
- Liability of the PRRC.
Who Should Attend?
- Persons that will be responsible for regulatory compliance
- Authorized representatives
- RA manager, RA director, QA manager, QA director
- Professionals preparing for the MDR/IVDR.
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