
11 Jul What is a PRRC (Person Responsible for Regulatory Compliance)?
Learn More about the Role of a PRRC
The Person Responsible for Regulatory Compliance (PRRC) is a pivotal role introduced by the European Union’s Medical Device Regulations (MDR) and In Vitro Diagnostic Regulations (IVDR) under Article 15. As of 2017, all manufacturers, regardless of size, are required to appoint a PRRC to ensure regulatory compliance of their medical devices or in vitro diagnostic (IVD) devices. This role is critical to ensuring that companies meet their legal obligations while safeguarding product quality and patient safety.
In this article, we will explore the qualifications needed to become a PRRC, the duties and responsibilities of the role, and its importance in the medical device and IVD sectors.
Qualifications Needed
To be appointed as a PRRC, a professional must meet specific educational and experience requirements, as outlined in Article 15. The regulation mandates that the PRRC must hold one of the following:
- Diploma or Certificate: The individual must have a formal qualification in disciplines such as medicine, law, pharmaceutical sciences, engineering, or other life sciences.
- Experience: In addition to the educational qualification, the person must have at least one year of professional experience in regulatory affairs or quality management systems relevant to medical devices.
Alternatively, if an individual does not possess the formal educational background, they may still qualify if they can demonstrate four years of relevant experience in regulatory affairs or quality management.
This flexible framework allows organisations of all sizes, including small and micro-enterprises, to either employ or outsource their PRRC duties. For smaller organisations lacking internal regulatory expertise, outsourcing the PRRC responsibilities is permitted as long as the person meets the necessary qualifications and experience.
Duties of a PRRC
The PRRC’s role is structured around ensuring compliance across five key areas, as outlined in Article 15 of the MDR and IVDR:
- Conformity of Devices: The PRRC is responsible for ensuring that each batch of devices complies with the organisation’s quality management system. Although the PRRC does not have to personally perform each step, they must ensure that processes are correctly followed and documented.
- Technical Documentation: The PRRC must ensure that the technical documentation and the Declaration of Conformity are prepared and kept up to date. This documentation is critical for demonstrating that a device meets all applicable regulatory requirements before it is placed on the market.
- Post-Market Surveillance: The PRRC must oversee the post-market surveillance obligations of the company. This includes gathering, recording, and analysing performance data on devices that are already in use to ensure they continue to meet safety and performance standards.
- Vigilance Reporting: It is also the PRRC’s duty to ensure that the company meets its obligations to report serious adverse events (SAEs) or other significant issues that might arise from the use of its devices. Vigilance is essential for managing risks and improving device safety.
- Compliance for Investigational Devices: Finally, the PRRC ensures that investigational or performance evaluation devices meet all applicable safety and performance requirements during clinical or performance trials. This aspect is particularly significant before a device has received the necessary CE marking for commercial distribution.
Responsibilities and Authority
The PRRC is not merely a figurehead but a central authority within a company responsible for regulatory compliance. Unlike traditional roles in regulatory affairs, the PRRC’s responsibilities are publicly visible, with their name and contact details registered in Eudamed, the European database for medical devices.
The PRRC must ensure that all processes related to device safety and performance are properly documented and executed. In practice, this involves collaborating with multiple departments within a company, such as quality assurance, clinical evaluation, and risk management, to maintain compliance across all stages of the product lifecycle. This coordination can be compared to being a “conductor of an orchestra,” as the PRRC must ensure that all activities align with regulatory requirements without directly carrying out each task.
However, it is important to note that the PRRC is not held solely responsible for all aspects of compliance. They must ensure compliance processes are established and followed, but they are not expected to perform the technical or operational tasks themselves. Nevertheless, the PRRC bears the final responsibility for ensuring that everything is in order and compliant with the law.
Importance of the Role in Medical Device and IVD Companies
The introduction of the PRRC role reflects the EU’s commitment to improving safety and accountability in the medical device and IVD sectors. By requiring a designated person to oversee regulatory compliance, the EU ensures that there is a clear line of accountability within every organisation, whether large or small. This is particularly important in light of recent scandals and device failures that have emphasised the need for robust oversight in the industry.
- Mitigating Compliance Risks: With the growing complexity of the MDR and IVDR, the PRRC acts as a safeguard, reducing the risk of non-compliance. Failure to comply with regulations can result in hefty penalties, product recalls, or even the revocation of CE marking, which can have severe financial and reputational repercussions for a company.
- Strengthening Public Confidence: By assigning a responsible person, medical device companies can enhance transparency and trust in their operations. The PRRC acts as a public representative for the organisation’s compliance, giving external parties—such as regulatory bodies, auditors, and customers—confidence that the company is committed to maintaining high safety and performance standards.
- Enabling Efficient Audits: The PRRC plays a crucial role during audits conducted by Notified Bodies or Competent Authorities. During these audits, the PRRC must demonstrate that the organisation has implemented the appropriate measures to ensure compliance with the MDR or IVDR. One of the common challenges identified in early audits is the failure to appoint a qualified PRRC or to provide sufficient documentation of their qualifications and role.
- A Future-Ready Role: The PRRC role also helps companies prepare for future regulatory challenges, especially as regulations continue to evolve. In the UK, for instance, the regulatory framework post-Brexit may soon introduce a similar requirement to the PRRC, meaning that companies operating both in and outside the EU will benefit from establishing this role early.
Summary
The Person Responsible for Regulatory Compliance (PRRC) plays an essential role in ensuring that medical devices and IVDs meet the stringent requirements of the EU MDR and IVDR. With qualifications that encompass both academic and practical regulatory experience, the PRRC is responsible for overseeing conformity, technical documentation, post-market surveillance, and vigilance reporting. By acting as a central figure in regulatory compliance, the PRRC not only ensures the company adheres to legal obligations but also builds trust with regulatory bodies and the public, making this a vital role for the future of the medical device and IVD industries.
Watch the full interview below
Written by Educo Life Sciences Expert, Anne Jury
Anne Jury is a consultant and trainer in medical devices EU & UK regulatory compliance and quality assurance systems. Starting out as company microbiologist for Smith & Nephew Textiles Anne went on to work for Notified Bodies, BSI and then TÜV Product Service as a lead auditor and later as UK Regional Manager. Anne is also Vice-President of Team-PRRC, a non-profit organization set up in March 2020 to support individuals in the role of PRRC under the EU medical device regulations.
This article was written from video interviews conducted with Anne (you can watch one of them above).
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