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PRRC | Person Responsible for Regulatory Compliance

With the Medical Device Regulation (MDR EU 2017/745) and In Vitro Diagnostic Regulation (IVDR EU 2017/746), European regulators aim to ensure companies have a regulatory expert – a Person Responsible for Regulatory Compliance (PRRC) – at their disposal, to ensure that the company is meeting certain specific EU requirements. The responsibilities of the PRRC are also set in the Regulations and interpreted in the MDCG Guidance 2019-7.

Qserve organizes training for persons that will be appointed by manufacturers or Authorized Representatives as PRRC.

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


There is an option to receive a personal certificate for this training, showing you have successfully qualified as PRRC. The personal certificate will detail the learning objectives, and if you fulfill the requirements of the MDR/IVDR for qualifying as PRRC (experience and background). The certificate is personal and can be shown to Notified Bodies during audits.

The certificate costs € 375,-.


We offer open enrollment, on-location, and train-the-trainer formats. Please contact us to schedule in-house training, which is recommended for training multiple colleagues or teams simultaneously.

You can contact us for more information

For more information about this course and/or in-house training for your organization, please fill in the contact form below. 

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