27 Jan The figure of PRRC, the Person Responsible for Regulatory Compliance, appears.
The Medical Devices and In Vitro Diagnostic Regulations (MDR 745/IVDR 746) have established a new role for manufacturers and their authorised representatives, if the manufacturer is not located in the EU. This is the “person responsible for regulatory compliance”. This PRRC has certain obligations and must meet certain requirements, which are explained below.
What obligations does the person responsible for compliance have?
The PRRC must carry out supervision and control of the manufacture of the products and post-market surveillance and vigilance activities.
It must also ensure that the technical documentation of the products manufactured is up to date with all applicable standards, common specifications and regulations.
In its chapter on the Quality Management System, the text states that the system documentation must include a description of a number of procedures and techniques. Among these is a specific call for a compliance strategy. This strategy should be carried out by the PRRC.
How do these two points affect the CE marking of my medical device?
On the one hand, it means that, once the CE marking has been obtained, the manufacturer is obliged to keep up to date with the regulations that apply to its products. The manufacturer must also implement any necessary changes.
It also stipulates that in order to obtain CE marking, a Quality Management System including a compliance strategy must be developed.
Requirements of the person Responsible for compliance with the regulations
The PRRC has to demonstrate that it has the necessary experience and/or training in the field of medical devices. This can be demonstrated in one of the following ways:
- A degree in law, medicine, pharmacy, engineering or other relevant scientific discipline, plus at least one year of professional experience in regulatory affairs or medical device quality management systems, or;
- Four years of professional experience in regulatory affairs or medical device quality management systems.