Since the publication of the revised EU regulatory framework for medical devices (MDR 2017/745 and IVDR 2017/746), many innovations must be implemented to ensure compliance with the MDR/IVDR environment. One of them is the Person Responsible for Regulatory Compliance (PRRC).
This responsible person must comply with specific qualifications and assume essential tasks in the manufacturer's organisation.
In this course, the background of the revised regulations and 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 allows the tasks to be distributed among more than one person.
But how must responsibilities be defined, and how can the PRRC ensure oversight of 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.