PRRC  (Person Responsible for Regulatory Compliance)

Agenda

The MDR (2017/745)  and IVDR (2017/746)  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.                                                                                                                                                

Module 1  MDR 2017/745 and 2017/746 IVDR PRRC requirements and where they are coming from.

Module 2  Roles and responsibilities of PRRC.

Module 3  Qualifications of PRRC.

Module 4  Interconnectivity of  PRRC and your QMS

Module 5  Check the conformity of the devices.

Module 6  Post-market surveillance obligations.

Module 7 Reporting obligations for recording and reporting of incidents and field safety corrective actions.

Learning Objectives                                                                                                                 In this 2 day training you will learn what you need to know about the role as PRRC, which is mandatory for Medical and In Vitro Diagnostic Device Manufacturers.

We will get knowledge of what the role covers and how this role should be implemented from a regulatory perspective. The course is aimed at individuals appointed PRRC or for economic operators that need a PRRC.