The Vital Role of the Person Responsible for Regulatory Compliance (PRRC)

The concept of a “Person Responsible for Regulatory Compliance” (PRRC) is a role introduced by the European Union’s Medical Device Regulation (MDR) 2017/745 and In Vitro Diagnostic Regulation (IVDR) 2017/746. But who is this individual, and why does their role matter so much in the medical devices sector? Let’s go deeper into the importance of PRRC and its implications for manufacturers and users.

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Understanding the Background
Before explaining the specific responsibilities and qualifications of a PRRC, it’s vital to understand the context in which this role was introduced. In previous years, Europe witnessed several high-profile cases related to the safety and efficacy of medical devices. Such episodes demonstrated a need for tighter regulatory oversight, ensuring products that reach the market are safe and deliver on their promises.

The introduction of the MDR and IVDR was a direct response to these challenges, emphasizing greater transparency, enhanced patient safety, and stricter oversight. Among the many changes was the introduction of the PRRC role.

Key Responsibilities of a PRRC
Ensuring Conformity: The PRRC must ensure that the manufacturing and design of medical devices and in vitro diagnostic medical devices (IVDs) comply with the regulations. They are the gatekeepers, ensuring that products are fit for purpose and safe for use.

Technical Documentation Management: The PRRC has a duty to ensure the proper preparation and maintenance of technical documentation and the EU Declaration of Conformity. This means they are deeply involved in the pecifics of of device design, function, and clinical evaluations.

Vigilance and Incident Reporting: If a device causes an adverse event, or if there’s a potential for such an event, the PRRC must ensure that these incidents are reported promptly to the relevant authorities. Their role in post-market surveillance also means they keep an eye on real-world device performance, ensuring continuous safety after the product’s launch.

Post-market Surveillance: Beyond adverse events, the PRRC oversees the broader post-market surveillance system, ensuring that any feedback, whether positive or negative, from users and patients is captured, analyzed, and acted upon.

Qualifications of the PRRC
The PRRC must possess the necessary qualifications, which vary depending on the type of device and the company’s activities., the regulations are clear about who can assume the role of a PRRC:

Formal Qualifications: A university degree in fields like law, medicine, pharmacy, or engineering provides the foundational knowledge for a PRRC. These disciplines give an understanding of both the scientific and legal landscapes of medical device regulation.

and/or

Professional Experience: At least one (1) year of professional experience in regulatory affairs or in quality management systems related to medical devices. If the individual doesn’t have a university degree, they must have at least four (4) years of professional experience in the field.

The Impact on Manufacturers
Every medical device and IVD manufacturer with ambitions to sell in the EU needs a PRRC. This means:

In-house or Outsourced: Large manufacturers may have a dedicated department for regulatory compliance with a designated PRRC, while smaller entities might assign this role to an existing employee. For micro and small businesses, the PRRC can even be an external consultant, provided they’re continually available to the manufacturer.

Continuous Training: Given the evolving nature of medical device regulations and technologies, continuous training and development become essential for PRRCs. Manufacturers must ensure that their PRRCs are always updated with the latest in the regulatory landscape.

A Cultural Shift: The introduction of the PRRC role signifies a shift towards a more patient-centric and safety-first approach. It will likely drive a cultural change in manufacturers, emphasizing rigorous internal checks and balances.

The PRRC isn’t just a title; it’s a commitment to patient safety, product efficacy, and the highest standards of integrity. For medical device and IVD manufacturers, the PRRC plays a crucial role in making sure their products uphold the strict standards of the European market.

If you’re finding the IVDR tough to navigate, don’t worry – QRcompliance is here to help. Visit our website at www.qrcompliance.nl. We also provide a selection of templates in our online shop to assist you in setting up compliant documentation seamlessly. Let QRcompliance guide you through the intricacies of the IVDR.

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