The Medical Device Regulation (MDR) is a comprehensive regulation aimed at ensuring the safety and effectiveness of medical devices within the European Union (EU). One crucial requirement of the MDR is the appointment of a Person Responsible for Regulatory Compliance (PRRC).
In this article, we will delve into the responsibilities of the PRRC as outlined in the MDR, highlighting common pitfalls and challenges associated with this role. Additionally, we will explore the expectations of notified body auditors regarding the competence and qualification of the PRRC.
Responsibilities of the PRRC
According to Article 15 of the MDR, the PRRC is responsible for ensuring compliance with regulatory requirements throughout the lifecycle of a medical device. The primary duties of the PRRC include:
1. Overseeing conformity assessment
The PRRC is pivotal in ensuring medical devices conform to the MDR requirements. They must understand the applicable regulations and potential standards and actively participate in product management.
Even if the MDR does not specifically define it as an area of PRRC responsibility, understanding of conformity assessment procedures is crucial.
2. Monitoring post-market surveillance (PMS)
The PRRC is responsible for PMS management for monitoring the safety and performance of medical devices on the market. They should ensure timely reporting and implement appropriate corrective and preventive actions.
3. Complexity of compliance
The MDR introduces significant changes and increased requirements compared to the previous regulatory framework. PRRCs may face challenges in interpreting and implementing these complex requirements, necessitating ongoing training and upskilling, which training can support.
The PRRC plays a vital role in ensuring regulatory compliance throughout the lifecycle of medical devices under the MDR. Their responsibilities span product conformity, post-market surveillance, vigilance, and potential collaboration with competent authorities. Notified body auditors expect PRRCs to be trained and qualified, with course certificates or records as evidence of their proficiency.
By being aware of common pitfalls and challenges, such as the complexity of medical device manufacturing, technical documentation management, reporting obligations, and coordination, PRRCs can navigate their role successfully, contributing to the safety and effectiveness of medical devices in the EU market.
Would you like to know more about PRRC?
Take a look at our online Introduction to PRRC – Person Responsible for Regulatory Compliance course that focuses on the needs of the PRRC (Person Responsible for Regulatory Compliance) according to article 15 of the EU MDR. It deals with the requirements and how to ensure the PRRC fulfils their responsibilities.
Participants learn how to work with the MDR, the obligations of the manufacturer, the PRRC specific responsibilities, and post market surveillance. The course is relevant for PRRC’s or persons needing to understand the requirements related to the PRRC role.
Pontus Gedda is a dedicated medical device specialist that has worked both in the industry, as a design engineer and project manager, and in the notified body world as a medical device lead auditor and manager.
He has vast experience in the MDR and its implementation thru hands-on experience from implementing the MDR at a notified body and leading that notified body through a joint assessment and getting designated as an MDR notified body.
He was a senior manager at a notified body during the transition from MDD to MDR and also a member of the NB-MED group.