COURSE TRAINER
Antje Tandetzky

FOR MORE INFORMATION
Please contact us for further details about the training programme, course content and availability.

Info@ellecom.de

PERSON RESPONSIBLE FOR REGULATORY COMPLIANCE (PRRC)

Understanding the Role and Responsibilities under the EU MDR

DURATION
1 Day

COURSE OVERVIEW

This one-day training provides participants with a structured understanding of the Person Responsible for Regulatory Compliance (PRRC) and the requirements associated with this role under Regulation (EU) 2017/745 (MDR).

Participants will explore the tasks and responsibilities of the PRRC, the necessary qualifications and prerequisites for the role, and relevant considerations regarding responsibility and liability. The training also examines the practical implications of appointing an internal or external PRRC, as well as considerations when regulatory responsibilities are shared between more than one person.

WHAT YOU WILL LEARN

The course provides practical insight into the responsibilities of the PRRC and how the role interacts with an organization's Quality Management System and regulatory processes. Participants will also consider how the appointment and positioning of the PRRC can affect organizational responsibilities and internal processes.

The training further addresses relevant considerations for manufacturers of legacy devices and helps participants understand the PRRC role within the broader regulatory framework of the EU MDR.

WHO SHOULD ATTEND

This training is intended for Quality Managers, Development Managers, Regulatory Affairs Managers, Managing Directors, and other professionals who need to understand the responsibilities and organizational implications of the PRRC role.

TRAINING MATERIALS

Participants receive a training presentation, course forms and training textbook. Regulation (EU) 2017/745 (MDR) is used as a key regulatory reference throughout the training.

CERTIFICATE OF ATTAINMENT

Upon successful completion of the training, participants receive an ELLECOM Certificate of Attainment for Person Responsible for Regulatory Compliance (PRRC) training.