The Person Responsible for Regulatory Compliance (PRRC): A Key Role under the EU MDR

The role of the Person Responsible for Regulatory Compliance (PRRC) was introduced by the European Regulation (EU) 2017/745 (MDR) in Article 15. This article specifies both the tasks of the PRRC and the professional qualifications required to hold this position.

Who can legally take on this role?

According to the MDR, the designated PRRC must hold a diploma or university degree in law, medicine, pharmacy, engineering, or another relevant scientific discipline, and must have at least one year of professional experience in regulatory affairs or quality management systems related to medical devices.

If no academic qualification is held, a minimum of four years of professional experience in the field is required.

It is essential to ensure that the appointed person meets these qualifications and that the evidence is properly documented, as notified bodies now systematically check this point during audits. Moreover, the name of the PRRC must be registered in the Economic Operators module of the Eudamed database, and this information is publicly accessible.

In micro and small companies, it is common that no employee meets these criteria. Fortunately, the MDR allows this role to be outsourced, provided the PRRC is available to the manufacturer at all times and without interruption. In larger companies, the designated PRRC will naturally be someone from the Quality or Regulatory Affairs team. It is also possible to appoint several PRRCs within the same organization, in which case the scope of responsibility of each individual must be clearly defined in writing.

What does the PRRC actually do?

How, in practice, should the PRRC “ensure regulatory compliance”? The MDR precisely defines the PRRC’s responsibilities, which are structured into five key tasks. The PRRC must ensure that:

• device conformity is properly checked, in accordance with the quality management system, before a device is released;

• technical documentation and the EU Declaration of Conformity are drawn up and kept up to date;

• post-market surveillance obligations are fulfilled;

• vigilance obligations are fulfilled;

• for devices subject to clinical investigation, the statement confirming compliance with the general safety and performance requirements is issued (independently of the clinical investigation itself).

It is important to note that the PRRC does not have to personally perform all these tasks. Rather, their role is to ensure that these tasks are effectively carried out within the company. The challenge lies in defining how the PRRC can fulfill this mission safely, efficiently, and appropriately within the company’s structure. In practice, a job description should be drafted, and above all, quality management procedures should be updated to specify clearly when and how the PRRC intervenes in these processes.

A key role involving authority and accountability

The introduction of the PRRC role reflects the legislator’s intent to ensure that manufacturers’ obligations are truly met in practice. By naming a specific individual who is accountable for compliance with the MDR, the regulation places clear responsibility both on the PRRC and on the manufacturer.

For non-EU manufacturers, oversight is reinforced, as their European Authorized Representatives must also appoint a PRRC to provide an additional level of control.

To ensure PRRCs can properly exercise their responsibilities, the MDR specifies that they must not suffer any disadvantage for correctly performing their duties. In case of non-compliance, the PRRC must have the authority to raise the alarm and trigger corrective actions.

This pressure can be significant for the person in charge. Moreover, if the PRRC fails to properly carry out their mission, they may incur personal liability. While this liability is relatively limited for internal employees, the situation is different for external PRRCs, making professional liability insurance a critical matter to settle before signing any contract.

Need help?

Whether you are a manufacturer or an authorized representative (European or Swiss), we can support you in practically implementing the PRRC role within your organization, or we can take on this responsibility as an external PRRC. Do not hesitate to contact us to discuss your needs!