Two colleagues at the office

PRRC: All You Need to Understand

ByOumaya I.

The Regulation (EU) 2017/745 on Medical Devices (MDR) requires manufacturers to appoint a Person Responsible for Regulatory Compliance (PRRC). This obligation applies to all medical device manufacturers, including those developing Software as a Medical Device (SaMD).

For small businesses and start-ups, this requirement may seem burdensome due to limited resources and the complexity of regulatory compliance. However, the regulation includes provisions that allow, under certain conditions, the outsourcing of this function.

What is the PRRC and What is Their Role?

The PRRC plays a crucial role in a medical device manufacturer’s organization by ensuring that the product complies with MDR regulatory requirements. Their main responsibilities include:

  • Supervising the compliance of medical devices before they are placed on the market.
  • Validating and updating the technical documentation, including the technical file and the Declaration of Conformity.
  • Post-market surveillance and vigilance, ensuring the monitoring of incidents and corrective actions.
  • Reporting serious incidents and corrective actions to the competent authorities.
  • Ensuring compliance with quality management system (QMS) requirements.

Who Can Be a PRRC?

Article 15 of the MDR outlines the qualifications required to be designated as a PRRC. A person can fulfill this role if they meet one of the following conditions:

  • Option 1: Hold a university degree (or a diploma recognized as equivalent by an EU Member State) in a relevant field such as law, medicine, pharmacy, engineering, or another scientific discipline, and have at least one year of professional experience in regulatory affairs or quality management systems related to medical devices.
  • Option 2: Have four years of professional experience in regulatory affairs or quality management systems related to medical devices.

It is essential that the PRRC has a thorough understanding of the regulatory requirements applicable to medical devices and ensures compliance with the regulations. The manufacturer must be able to demonstrate that the designated individual meets these requirements through supporting documents such as diplomas and experience attestations.

Who Needs to Appoint a PRRC?

Several types of organizations must appoint a PRRC:

1. Medical Device Manufacturers

Any manufacturer established in the EU must have a PRRC within their organization who meets the qualification criteria defined by the MDR. For companies with more than 50 employees and an annual turnover exceeding €10 million, the PRRC must be an internal employee.

2. Micro and Small Enterprises

Micro and small enterprises (fewer than 50 employees and an annual turnover of less than €10 million) are allowed to outsource the PRRC, provided that this person is permanently and continuously available for the company and meets the qualification criteria outlined in Article 15 of the MDR.

3. Importers, Distributors, and Other Entities Assuming Manufacturer Responsibilities

According to Article 16 of the MDR, importers and distributors who:

  • Place a device on the market under their own name,
  • Change the intended purpose of an existing device,
  • Modify a medical device in a way that affects its compliance,

are considered manufacturers and must also appoint a PRRC.

4. Authorized Representatives of Non-EU Manufacturers

Authorized representatives must have a permanently and continuously available PRRC. This PRRC cannot be the same person as the PRRC of the non-EU manufacturer, ensuring independent oversight of devices placed on the European market.

Outsourcing the PRRC: An Option for Small Businesses

Outsourcing the PRRC function for micro and small enterprises is regulated by the Recommendation 2003/361/EC, which defines such businesses as those with fewer than 50 employees and an annual turnover of less than €10 million. This provision allows small businesses to comply with MDR requirements without having to maintain a dedicated in-house PRRC.

Article 15 of the MDR (see Article 15) states that these businesses can outsource this function under specific conditions. In this case, they must engage a person or organization that meets the regulatory competence criteria.

Conditions for Outsourcing the PRRC

  • The external PRRC must have a clear contract with the manufacturer specifying their responsibilities.
  • They must have access to all technical documentation and compliance records.
  • They must be easily reachable and able to fully assume their supervisory role.

Useful Links