Virtual Training: PRRC | Person Responsible for Regulatory Compliance

February 14, 2023

Date: 14th (1) and 28th of February  (2) 2023 (2 sessions)

Time: 14:00h - 17:00h CEST | 8:00 - 11:00 am EST

Location: Virtual

Language: English

Costs: € 895,- / $990

The certificate is optional, and will cost an additional € 375,- / $425


The MDR and IVDR require that manufacturers and authorized representatives have a person responsible for regulatory compliance. Article 15 of the MDR/IVDR determines the expertise and responsibilities. These have been further clarified in the recent guidance MDCG 2019-07. Qserve organizes training for persons that will be appointed by manufacturers or authorized representatives as PRRC.

There is an option to receive a certificate for this training, showing you have successfully qualified as PRRC. The 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 personalized and can be shown 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


Post date: November 08, 2022
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