What is a PRRC?

What is a PRRC?

The Person Responsible for Regulatory Compliance (PRRC) is a pivotal role within the Quality Management System (QMS) structure of any product manufacturing company, but in particular for regulated industries such as medical devices / in-vitro diagnostic devices.

Is it a legal requirement to have one?

Appointing a PRRC is a requirement of the European Union’s Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Device Regulation (IVDR 2017/746).

“Manufacturers shall have available within their organisation at least one person responsible for regulatory compliance who possesses the requisite expertise in the field of medical devices.”

The PRRC ensures that products meet all regulatory requirements throughout their lifecycle; from design and manufacturing, through to post-market surveillance and associated vigilance and reporting activities.

Who can be a PRRC?

One area that is often overlooked for the PRRC is the matter of competence. To fulfil the responsibilities of the PRRC as specified in the Regulations, the individual must possess specific qualifications and/or expertise:

• Educational Background: “a diploma, certificate or other evidence of formal qualification, awarded on completion of a university degree or of a course of study recognised as equivalent by the Member State concerned, in law, medicine, pharmacy, engineering or another relevant scientific discipline, and at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices”
• Professional Experience: “four years of professional experience in regulatory affairs or in quality management systems relating to medical devices.”

For manufacturers of custom-made devices, the PRRC must have at least two years of professional experience within a relevant field of manufacturing.

What are the core responsibilities for the PRRC?

The person responsible for regulatory compliance shall at least be responsible for ensuring that:

(a) the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released;

(b) the Technical Documentation / File and the EU declaration of conformity are drawn up and kept up-to-date;

(c) the post-market surveillance obligations are complied with;

(d) the reporting obligations are fulfilled.

What are the business or personal risks if the PRRC does not meet requirements?

Not having a person with the sufficient knowledge and experience in the role of the PRRC can create wasted time and money during activities relating to a company’s medical devices, such as product development and if occurring, compliant resolution with the relevant authorities. In the worse-case situation, it could also lead to dangerous devices being placed on the market.

Failure to comply with reporting obligations can lead to regulatory sanctions and damage to the company’s reputation.

Can I outsource the PRRC role?

Small and micro-enterprises may outsource the PRRC role to an external expert, provided the individual meets the necessary qualifications and is permanently and continuously available to the manufacturer. An agreement must be in place between both parties, and the outsourced PRRC must be listed as a critical supplier in the manufacturer’s quality system. 

Why choosing the right PRRC for your company is so important:

The PRRC is integral to ensuring that products not only meet regulatory requirements but also uphold safety and quality standards throughout their lifecycle. By overseeing conformity assessments, maintaining technical documentation, managing post-market surveillance, and ensuring compliance with reporting obligations, the PRRC plays a crucial role in safeguarding public health in relation to their medical devices and maintaining the manufacturer’s ongoing credibility in the marketplace.