Since the publication of the revised EU regulatory framework for medical devices (MDR 2017/745 and IVDR 2017/746), many innovations need to be implemented to insure compliance to the new environment. One of them is the Person Responsible for Regulatory Compliance (PRRC). This "responsible person" has important tasks and duties in the manufacturer organization.
In this course, the background of the revised regulations as well the tasks and responsibilities of the PRRC are explained in detail. It could be difficult for a single person to fulfil all of them. The legislation therefore provides for the tasks to be distributed among more than one person. But how do responsibilities have to be defined and how can the PRRC insure to have oversight on the most critical processes? What are the internal interfaces and what should be prepared for this new role?
The course is dedicated exactly to these questions. It shows ways and possibilities how to make the necessary preparation and will give you practical tips to meet the challenges and find out more about the most important aspects for the daily practice.