17th (1) and 24th of March (2) 2022 (2 sessions)
Time: 14:00h - 17:00h CET
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 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.
- 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