As the EU MDR ushers in a new era of stringent regulatory oversight, the role of the Person Responsible for Regulatory Compliance (PRRC) takes center stage. This pivotal position is instrumental in ensuring that medical devices placed on the European market adhere to the highest standards of safety, quality, and performance. In this blog, we’ll explore the multifaceted responsibilities of the PRRC and their crucial role in the conformity assessment process.
The PRRC is an individual designated by the manufacturer to take responsibility for regulatory compliance of medical devices in accordance with EU MDR. This role is mandatory for manufacturers, importers, and distributors, and the PRRC must reside within the European Union.
One of the main, and most obvious, responsibilities of the PRRC for an organization is to maintain and ensure compliance. This includes overseeing the conformity assessment process, maintaining technical documentation, and ensuring compliance with essential principles and safety requirements.
The PRRC also plays a critical role in post-market surveillance, overseeing activities such as Post-Market Clinical Follow-up (PMCF) and Post-Market Performance Follow-up (PMPF). Monitoring the performance of devices in the post-market phase allows the PRRC to identify and address any emerging safety concerns.
The PRRC acts as a liaison between the manufacturer and competent authorities, facilitating communication and providing the necessary information to demonstrate compliance. This collaboration ensures a transparent and efficient regulatory process.
EU MDR outlines specific qualifications and expertise required for individuals holding the PRRC role. This includes possessing knowledge of the medical device regulations, understanding of the relevant scientific and technical aspects, and experience in regulatory affairs.
The PRRC plays a critical role for any organization marketing their device in the EU, ensuring that medical devices entering the European market meet the highest standards of safety and performance. Their vigilance and expertise contribute significantly to the overall integrity of the medical device industry under EU MDR.
Are you looking to begin marketing, or keep your current marketing status, in the EU? Do you need support with transition of your QMS or technical files? EMMA’s EU MDR experts can help support you through EU MDR transitions all the way to conformity assessment prep and beyond. Call us at 248-987-4497 or email info@emmainternational.com to learn more!
A. Jury, M. Pinsi BSI (May 2023) Person Responsible for Regulatory Compliance (PRRC) retrieved from: https://www.bsigroup.com/globalassets/meddev/localfiles/fr-fr/whitepapers/wp—person-responsible.pdf
