Final Thoughts on PRRC under MDR and IVDR

Under the European Union’s Medical Device Regulation (EU MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746), it is mandatory for manufacturers and authorized representatives to appoint a Person Responsible for Regulatory Compliance (PRRC). This key regulatory role ensures that medical and in vitro diagnostic devices placed on the EU market fully comply with applicable regulatory requirements throughout the product lifecycle.

The PRRC requirement is clearly outlined in Article 15 of both MDR and IVDR, and further clarified in MDCG Guidance 2019-7. The guidance interprets the qualifications and responsibilities of the PRRC and reflects the EU's strong emphasis on accountability and oversight in medical device regulation. As the industry moves toward greater scrutiny, having a competent PRRC in place is not only a compliance obligation—it is a strategic imperative for businesses operating within or exporting to the EU.

The obligation to appoint a PRRC is not limited to EU-based manufacturers. The following stakeholders must also comply with the requirement:

• EU-based Manufacturers
   
• Authorized Representatives (for non-EU manufacturers)
   
• Certain Importers and Distributors
  In particular, importers and distributors who repackage, relabel, or make substantial changes to a device must also designate a PRRC. This applies in the following scenarios, as outlined in Article 16 of the MDR and IVDR:
   
• If the device is marketed under their name or brand, and the original manufacturer is not clearly identified (Article 16(1)(a)).
   
• If they change the primary packaging or intended purpose of a device already on the EU market (Article 16(1)(b)).
   
• If they modify a device in such a way that its regulatory conformity may be affected (Article 16(1)(c)).
   

Each of these actions may impact the product's safety, effectiveness, and regulatory standing, thereby necessitating oversight by a qualified PRRC.

Although the legislation remains silent on exact geographic requirements, MDCG Guidance 2019-7 emphasizes the need for a "permanent and continuous" relationship between the PRRC and the manufacturer's operations. Based on this principle:

• EU-based manufacturers are expected to appoint a PRRC who is physically located within the European Union.
   
• Non-EU manufacturers should ensure their PRRC is also based outside the EU, ideally in close proximity to their global manufacturing or regulatory hub.
   
• For virtual manufacturers—entities that source CE-marked products from an Original Equipment Manufacturer (OEM) and rebrand them—the obligation to appoint a PRRC still applies, even if no physical production is undertaken by the virtual manufacturer. They are recognized as legal manufacturers under the MDR/IVDR and must comply fully with PRRC requirements.
   

This approach ensures that the PRRC remains effectively connected to the day-to-day regulatory and quality activities associated with device development, release, and post-market management.

  Organizations—particularly larger or multinational ones—may appoint more than one PRRC to  fulfill various responsibilities. These roles can be strategically divided based on:

• Function: One PRRC may be responsible for ensuring the accuracy of technical documentation, while another may oversee conformity assessments or vigilance reporting.
   
• Geography: Different PRRCs may be assigned to specific manufacturing locations across the EU or globally, based on regulatory risk, volume, or product type.
   
• Device Classification: High-risk devices (e.g., Class III or Class D) may necessitate the appointment of dedicated PRRCs due to their complexity and higher scrutiny.
   

The qualifications and responsibilities of each PRRC must be clearly documented and registered in the EUDAMED database, in accordance with Section 2.4 of MDCG Guidance 2019-7. This ensures traceability and accountability for regulatory decisions.

MDCG Guidance makes a specific assumption for micro and small enterprises within the EU, suggesting that the PRRC must also be based in the EU. This ensures availability and close oversight of operations for businesses with limited regulatory infrastructure.

However, the guidance remains ambiguous regarding micro and small enterprises located outside the EU. In the absence of definitive regulatory interpretation, the best practice is to align with the same expectations applied to larger firms: the PRRC should be closely connected—geographically and operationally—to the manufacturer’s facility to maintain continuous availability and oversight.

For manufacturers operating multiple production sites or diverse product portfolios, the MDCG advocates for a risk-based approach to determine how many PRRCs are required and where they should be located. Factors to consider include:

• The complexity and classification of the devices.
   
• The scale and specialization of each manufacturing site.
   
• The regulatory maturity of internal systems across sites.
   

For example, a centralized PRRC may be suitable for several sites producing low-risk Class I or Class A devices, whereas Class III or Class D product lines may warrant dedicated PRRC oversight due to the elevated regulatory burden.

At RAPS (Regulatory Affairs and Professional Services), we recognize that fulfilling the PRRC requirements is not a one-size-fits-all solution. Whether you are:

• A startup navigating EU MDR/IVDR for the first time,
   
• A virtual manufacturer managing an OEM relationship, or
   
• A global medical device organization looking to harmonize your regulatory strategy,
   

we offer comprehensive PRRC consultancy and outsourcing solutions tailored to your organizational structure and risk profile.

Our services include:

• PRRC qualification assessments and appointment planning
   
• Cross-border PRRC support (EU and non-EU)
   
• Role separation for technical documentation, QMS, and post-market functions
   
• EUDAMED registration guidance
   
• Ongoing compliance and availability assurance
   

Let RAPS help you structure your PRRC oversight for efficiency, transparency, and regulatory alignment. Contact our team to learn more about our PRRC support solutions for EU MDR and IVDR compliance.