The Medical Device Regulation (MDR) implemented by the European Union (EU) places significant emphasis on the role of the Person Responsible for Regulatory Compliance (PRRC). In addition to their responsibilities, the MDR outlines specific requirements for the education and training of PRRCs.
This article will delve into the education and training obligations as defined by the MDR and shed light on auditors’ expectations, emphasizing the need for PRRCs to undergo specific training tailored to their role and maintain training records, including course certificates.
The MDR (Article 15, paragraph 2) stipulates that PRRCs must possess ”sufficient expertise in the field of medical devices.” While the regulation does not explicitly define the educational qualifications or specific training courses, it emphasizes the need for PRRCs to have the necessary knowledge and competence to fulfill their role effectively.
Notified body auditors, involved in assessing the compliance of medical devices, might have specific expectations regarding the education and training of PRRCs.
Auditors expect PRRCs to undergo training that specifically addresses the responsibilities and requirements of the PRRC role under the MDR. Generic or broad regulatory training may not be sufficient.
PRRC-specific training equips individuals with the necessary knowledge and skills to navigate the regulatory landscape and perform their duties effectively.
Auditors could request training records as evidence that the PRRC has received appropriate education and training.
Course certificates or other documented records that demonstrate the PRRC has completed training relevant to their role is essential. These certificates serve as tangible evidence of the PRRC’s qualifications and can aid in establishing compliance during audits.
PRRC-specific training offers several advantages:
Training tailored to the PRRC role provides a comprehensive understanding of the MDR requirements, conformity assessment procedures, post-market surveillance, vigilance, and interactions with other stakeholders. This knowledge equips PRRCs to effectively fulfil their responsibilities.
PRRC-specific training helps PRRCs stay updated with the evolving regulatory landscape and ensures adherence to the latest requirements. It helps mitigate compliance risks, reduces errors, and increases the likelihood of successful audits and certifications.
Training focused on the PRRC role enhances the competence of individuals by honing their skills and expertise. It enables PRRCs to make informed decisions, contribute to product quality, and ensure patient safety.
The MDR emphasizes the importance of education and training for the PRRC role. While the regulation does not specify precise educational qualifications, it stresses the need for PRRCs to possess sufficient expertise in the field of medical devices.
Auditors normally expect PRRCs to undergo training specifically tailored to the PRRC role and maintain training records, including course certificates, as evidence of their qualifications. PRRC-specific training equips individuals with the knowledge and skills necessary to navigate the regulatory landscape, ensure compliance, and contribute to the safety and effectiveness of medical devices in the EU market.
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.
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