Date: 24th of October 2022
Time: 16:00h -18:00 CET
Location: Virtual
Language: English
Costs: € 395,-
Package deal (12 sessions): € 3750.-*
* Team Members with Different Roles & Responsibilities? No problem! We offer flexible options for your company, team, or individual experts. You can send different delegates from your company to the sessions and still qualify for the package.
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.
Learning objectives:
- Understand the background of MDR/IVDR to understand PRRC requirements and where the are coming from
- Identity the role and responsibilities of PRRC
- Understand how to implement the responsibilities of the QMS
- Understand the liability (or not?) of the PRRC
Trainer: