PRRC MDR IVDR: role, requirements and compliance duties
What is the role of the PRRC?
The person responsible for regulatory compliance (PRRC) plays a key role in ensuring continuous compliance with EU MDR (2017/745) and IVDR (2017/746) throughout the lifecycle of medical and in vitro diagnostic devices. This article outlines what the PRRC does and why it matters for manufacturers.
1. Qualifications and requirements of the PRRC
Article 15 of both regulations defines the specific qualifications needed to serve as a PRRC. Instead of relying on a symbolic role, companies must appoint someone with relevant expertise.
Education and experience:
A qualified PRRC holds a university degree in a scientific discipline, such as medicine, pharmacy, or engineering and has at least one year of experience in regulatory affairs or quality management systems (QMS). Alternatively, professionals without a degree must demonstrate four years of related experience.
Specialised competence:
The PRRC must fully understand the MDR/IVDR frameworks, risk management principles, conformity assessment procedures, and post-market obligations. In addition, they must know how to apply these rules to ensure product compliance.
Ongoing responsibility:
This individual actively supervises internal compliance efforts and continuously monitors regulatory updates. Therefore, the PRRC becomes a central reference for all matters related to regulatory alignment.
2. PRRC vs. QP in the United Kingdom
When the EU implemented the MDR, it required every medical device manufacturer and authorised representative to appoint a PRRC. Meanwhile, the UK introduced a comparable figure known as the Qualified Person (QP) under the UK MDR 2002. Although these roles share similar objectives, they differ in scope and implementation.
The PRRC contributes across the entire device lifecycle, from design and development to post-market surveillance. They verify technical documentation, oversee QMS compliance, and manage vigilance systems. In doing so, they help manufacturers maintain consistent regulatory alignment.
Conversely, the QP primarily focuses on the final product release. They ensure each device meets UK standards before it enters the market. Unlike the PRRC, the QP operates more narrowly within production and certification stages. Additionally, their responsibilities are still being defined within the UK’s post-Brexit regulatory framework.
In summary: the PRRC supports an integrated compliance strategy, while the QP concentrates on operational conformity at the release phase.
3. Integrating the PRRC into your Quality Management System (QMS)
For a company to fully benefit from a PRRC, it must embed this role into the broader QMS. When aligned correctly, the PRRC reinforces quality assurance across every department.
Processes and procedures:
The PRRC collaborates on document control protocols, supports audit planning, and ensures the implementation of corrective and preventive actions (CAPAs). As a result, the company gains a more robust compliance structure.
Cross-functional collaboration:
This role connects regulatory affairs with product development, manufacturing, and post-market teams. Such collaboration allows teams to detect issues early, respond faster to regulatory changes, and apply corrective actions more effectively.
Digital tools:
By using digital document management systems and integrated platforms, the PRRC can streamline workflows and improve traceability. These tools enhance their ability to track compliance and ensure accuracy.
The PRRC is not merely a requirement, it is a strategic position. This individual supports regulatory excellence, improves patient safety, and strengthens a company’s reputation in global medical device markets.
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