Date: 2nd of December(1) and 9th of December (2) 2021 (2 sessions)
Time: 13:30h - 17:00h CET
Costs: € 895,-
The certificate* is optional, and will cost an additional € 375,-Introduction
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.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