Training Features

Person Responsible for Regulatory Compliance (PRRC) under the EU MDR and IVDR

A comprehensive virtual training on the responsibilities and requirements of the Person Responsible for Regulatory Compliance (PRRC) under the EU MDR and IVDR.
Format

Virtual Training

Level

Basic

Date

13 and 19 February 2026

Time

14:00 - 17:00 CEST
8:00 - 10:00 am EDT

Duration

6 hours in total

Trainer

Robert Paassen

Certificate

Certificate included

Price

€ 1270 or equivalent currency

PRRC Training: Ensuring Compliance with EU MDR/IVDR Requirements

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. This training provides in-depth knowledge of the PRRC role and supports a clear understanding of the MDR/IVDR requirements, from clinical evaluation to labelling.
Training Overview
Agenda
Key Learning Objectives
What is included?
Training Dates
Who Should Attend?
Training Overview
The Person Responsible for Regulatory Compliance (PRRC) role, established under Article 15 of the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), has raised questions for many regarding required qualifications, responsibilities, liability, and administrative obligations.

Led by Robert Paassen, 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.
Key Learning Objectives
  • Gain insight into the background and intent of the MDR and IVDR to understand the origins and purpose of PRRC requirements
  • Identify the roles and responsibilities of the Person Responsible for Regulatory Compliance (PRRC)
  • Understand the required qualifications for serving as a PRRC
  • Explore the integration of the PRRC role within your Quality Management System (QMS)
  • Learn how to assess device conformity effectively and appropriately
  • Understand how conformity checks vary based on the device’s risk class and type
  • Know how to maintain up-to-date technical documentation and EU declarations of conformity
  • Recognize the PRRC's role in fulfilling post-market surveillance obligations
  • Understand reporting duties related to incidents and field safety corrective actions
  • Learn the PRRC’s responsibilities for devices involved in clinical investigations (MDR) or performance studies (IVDR)
  • Clarify the scope of liability associated with the PRRC role.
What is included in this live virtual training?
  • Direct access to an expert trainer.
  • Interactive and engaging training sessions.
  • Access to the Qserve Learn Training Portal.
  • A training certificate upon completion of the training.
Training Dates
This training is delivered over two sessions, each lasting 3 hours, providing a focused and efficient learning experience. The sessions will take place on 13 and 19 February 2026, allowing participants to absorb key information between training days while minimizing disruption to their daily work.

If the February training dates are not suitable, our e-learning on PRRC is available on-demand. More information.
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
Customized Team Training
We offer fully tailored team training programs designed around your specific products, processes, technologies, and challenges, ideal for addressing unique training needs or accommodating larger groups. Learn More.
Topics Discussed in the Training
  • Regulatory Framework & Background  - Overview of MDR and IVDR, origins and purpose of PRRC requirements (Article 15), and MDCG 2019-07 Guidance. 
  • Roles & Responsibilities of the PRRC - Key duties under MDR and IVDR, ensuring compliance with regulatory requirements, and interaction with Notified Bodies and Competent Authorities. 
  • Qualifications & Eligibility - Experience and background requirements, and meeting the criteria to be appointed as PRRC. 
  • Quality Management System (QMS) Integration - Role of the PRRC within the QMS, and compliance oversight responsibilities. 
  • Conformity Checks & Documentation Maintenance - Ensuring device conformity proportionate to risk class, and keeping technical documentation and EU Declaration of Conformity up-to-date.
  • Post-Market Surveillance (PMS) & Vigilance - Monitoring and fulfilling PMS obligations, and incident and field safety corrective action (FSCA) reporting. 
  • Clinical Investigations & Performance Studies - PRRC responsibilities for devices under clinical investigation (MDR), and PRRC role in performance studies (IVDR). 
  • Liability & Legal Considerations - Legal accountability of the PRRC, and implications of non-compliance.
Meet the Trainer

Robert Paassen

Robert Paassen is a Regulatory Affairs & Quality Assurance consultant specializing in EU MDR, serving as a Startup Lead, with expertise in clinical evaluations, quality management system remediation, CAPA management, risk management, and supporting audits.