Person Responsible for Regulatory Compliance (PRRC) Services

What is PRRC?

MDCG 2019-7 - rev.1

The Person Responsible for Regulatory Compliance (PRRC) is a key requirement under Article 15 of the EU Medical Device Regulation (EU MDR 2017/745) and In Vitro Diagnostic Medical Device Regulation (IVDR 2017/746). Manufacturers placing medical devices or IVDs on the European market must designate at least one qualified PRRC to oversee regulatory compliance activities.

The PRRC ensures that devices are manufactured and controlled in accordance with applicable regulatory requirements, technical documentation is maintained, post-market obligations are fulfilled, and regulatory compliance is continuously monitored. This role is essential for demonstrating compliance and achieving successful market access within the European Union.

PRRC Responsibilities under EU MDR and IVDR

In accordance with Article 15(3) of EU MDR 2017/745 and IVDR 2017/746, the Person Responsible for Regulatory Compliance (PRRC) is responsible for ensuring that:

• Device conformity is appropriately verified prior to market release in accordance with the Quality Management System (QMS).
• Technical Documentation and the EU Declaration of Conformity are prepared, maintained, and kept up to date.
• Post-Market Surveillance (PMS) obligations are fulfilled in accordance with Article 10 of the MDR and IVDR.
• Vigilance reporting requirements, including serious incident reporting, Field Safety Corrective Actions (FSCAs), and trend reporting, are met in accordance with Articles 87-91 of the MDR and Articles 82–86 of the IVDR.
• Applicable requirements for clinical investigations and performance studies are fulfilled, including the issuance of statements required under Annex XV.

For Authorized Representatives, the PRRC is responsible for ensuring compliance with the obligations specified in Article 11 of the MDR and IVDR.

The designated PRRC serves as a key regulatory function within the organization and must possess the qualifications and expertise required under Article 15 of the applicable regulation.

Who Can Serve as a PRRC?

Under Article 15 of EU MDR 2017/745 and IVDR 2017/746, a Person Responsible for Regulatory Compliance (PRRC) must possess the necessary expertise in medical device regulatory requirements.

A PRRC may qualify through

• A university degree or equivalent qualification in Law, Medicine, Pharmacy, Engineering, or another relevant scientific discipline, combined with at least one year of professional experience in regulatory affairs or quality management systems related to medical devices; or
• A minimum of four years of professional experience in regulatory affairs or quality management systems for medical devices.

For custom-made device manufacturers, the required expertise may also be demonstrated through at least two years of professional experience in a relevant manufacturing field, subject to applicable national requirements.

Manufacturers that do not have a suitably qualified individual in-house may appoint an external PRRC consultant to ensure ongoing compliance with EU regulatory requirements.

Who Requires a PRRC?

In accordance with Article 15 of EU MDR 2017/745 and IVDR 2017/746, all medical device and IVD manufacturers, as well as EU Authorized Representatives, must designate at least one qualified Person Responsible for Regulatory Compliance (PRRC). Each legal manufacturer is required to have access to a PRRC to ensure compliance with applicable regulatory requirements, including device conformity, quality management, post-market surveillance, and vigilance obligations.

For small and micro enterprises, the PRRC function may be outsourced to a qualified external consultant, provided that the individual is permanently and continuously available to the organization.

Organizations may appoint one or more PRRCs, as permitted under Article 15(4) of the MDR and IVDR, provided that all qualification requirements are met and responsibilities are clearly defined and documented to ensure full coverage of regulatory compliance obligations.

Appointment and Importance of a PRRC

The PRRC serves as a central regulatory oversight function within an organization, helping to integrate regulatory compliance into daily operations and strategic decision-making. By providing expert oversight of quality, compliance, and post-market activities, the PRRC helps manufacturers maintain regulatory control throughout the product lifecycle.

The introduction of the PRRC role under the MDR and IVDR reflects the European Union's commitment to strengthening accountability, patient safety, and product performance. A dedicated PRRC supports proactive compliance management, facilitates regulatory readiness, and helps organizations respond effectively to evolving regulatory requirements.

For manufacturers seeking CE marking and long-term access to the European market, an experienced PRRC provides confidence that regulatory obligations are being effectively managed, potential compliance gaps are identified early, and regulatory risks are minimized.

Whether appointed internally or through an external consultancy, the PRRC plays a vital role in supporting sustainable compliance and maintaining market access within the European Union.