Person responsible for regulatory compliance

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PRRC

In the realm of medical device manufacturing, ensuring regulatory compliance is paramount. Central to this effort is the designation of a Person Responsible for Regulatory Compliance (PRRC) within your organization. This individual, essential in navigating the complexities of medical regulations, must possess in-depth expertise in the medical device field.

To qualify as a PRRC, candidates must showcase their proficiency through one of two pathways:

1. Academic and Practical Experience: Achieve a certification by completing a degree in critical fields such as law, medicine, pharmacy, engineering, or a related scientific discipline, accompanied by at least one year of professional experience in regulatory affairs or quality management systems specific to medical devices.

2. Extensive Professional Experience: Acquire at least four years of dedicated professional experience in regulatory affairs or quality management systems related to medical devices.

For manufacturers of custom-made devices, demonstrating relevant expertise requires at least two years of professional experience in an appropriate manufacturing sector.

However, there is a concession for smaller enterprises. Manufacturers with fewer than 50 employees are not obligated to have an in-house PRRC but must ensure immediate access to a qualified individual when needed.

Responsibilities of a PRRC include:

• Ensuring device compliance with established quality management systems before market release.

• Maintaining up-to-date technical documentation and the EU declaration of conformity.

• Adhering to post-market surveillance requirements as specified in Article 10 (10).

• Fulfilling the reporting obligations outlined in Articles 87 to 91.

• Issuing necessary statements for investigational devices as delineated in Section 4.1 of Chapter II of Annex XV.

For comprehensive guidance on PRRC requirements and responsibilities, refer to the MDCG 2019-7 Guidance on Article 15 of the Medical Device Regulation (MDR) and the In Vitro Diagnostic Device Regulation (IVDR).

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