PRRC MDR

Why the PRRC is Essential

EU regulatory authorities require that a designated PRRC guarantees the compliance of devices released to the market. This includes oversight of:

Device conformity assessments
Post-market surveillance (PMS)
Vigilance and incident reporting

For manufacturers based outside the EU, the European Authorised Representative (EAR) typically appoints a PRRC to perform an independent compliance verification. However, the responsibilities and obligations of the PRRC are far broader than those of the EAR, as defined in Section 3, Chapter 1, Article 15 of the MDR and IVDR.

Who Must Have a PRRC?

According to Article 15 and related guidance, the following entities must designate at least one PRRC with relevant expertise and qualifications within the EU:

Manufacturers marketing devices in the EU
Authorized Representatives acting on behalf of non-EU manufacturers
Importers and Distributors under specific circumstances, including when they:
- Sell devices under their own name without another manufacturer identified on the label (Article 16.1(a))
- Change the primary packaging or intended purpose of a device already on the EU market (Article 16.1(b))
- Modify a device in a way that could affect its regulatory compliance (Article 16.1(c))

PRRC Qualifications

Per Article 15 and MDCG Guidance 2019-7, the PRRC must meet one of the following qualification paths:

Hold a university degree, diploma, or formal qualification in a relevant field plus at least one year of experience in European regulatory affairs or quality management related to medical devices, OR
Have a minimum of four years’ professional experience in European regulatory affairs or quality management for medical devices, without a formal university qualification.

Expertise in European regulatory frameworks and quality management systems (QMS) is essential. Experience exclusively in non-EU regulatory systems such as FDA regulations, without EU-specific knowledge, does not fulfill the requirements.

How RAPS Supports Your PRRC Needs

RAPS offers expert consultancy to help your organization identify, appoint, and train qualified PRRC personnel, ensuring full compliance with MDR and IVDR requirements. Whether you are an EU-based manufacturer or an authorized representative of a foreign entity, our team guides you through:

PRRC qualification assessment
Regulatory obligations and responsibilities
Ongoing compliance monitoring and documentation
Coordination with notified bodies and competent authorities

Location of Manufacturer's Person Responsible for Regulatory Compliance (PRRC)

While the MDR and IVDR regulations do not explicitly specify the required location of the Person Responsible for Regulatory Compliance (PRRC) in relation to the economic operator, the MDCG Guidance 2019-7 provides important direction on this topic.

Key Guidance on PRRC Location

The guidance stresses the importance of a permanent and continuous connection between the PRRC and the manufacturer’s operations. As a result:

For manufacturers outside the EU, the PRRC is generally expected to be located outside the EU.
For manufacturers within the EU, the PRRC should be located within the EU.

This ensures the PRRC can maintain close oversight of manufacturing and compliance activities.

Multiple PRRCs and Their Responsibilities

Legal entities may appoint multiple PRRCs to meet their organizational and operational needs. Different PRRCs can be assigned specific tasks, such as:

Maintaining and updating technical documentation
Verifying conformity of devices according to the Quality Management System (QMS)
Overseeing compliance at different manufacturing sites

Each PRRC’s qualifications and distinct responsibilities must be documented and registered in EUDAMED, per regulatory requirements. It is important to note that each legal manufacturer under a parent company needs a dedicated PRRC.

Managing Multiple Manufacturing Sites

Manufacturers with multiple sites may adopt a risk-based approach to determine the number and placement of PRRCs. Factors to consider include:

The variety and classification of devices produced
The complexity and risk level of the products

For example, a single PRRC may suffice for multiple low-risk devices, while higher-risk or more complex products might require several PRRCs to ensure full compliance.

Special Considerations for Virtual Manufacturers

Virtual manufacturers—companies that brand products designed and produced entirely by an Original Equipment Manufacturer (OEM)—are legally responsible manufacturers under MDR/IVDR. They must ensure PRRC requirements are fulfilled either directly or through their relationship with the OEM.

Small and Micro Enterprises

For micro and small enterprises based in the EU, MDCG Guidance 2019-7 assumes the PRRC should also be located within the EU to ensure permanent availability. However, for those outside the EU, the guidance is less clear, but it is generally presumed that the same principle applies: the PRRC should be situated close to the manufacturing activities.

How RAPS Can Assist

At RAPS, we help manufacturers and authorized representatives understand and implement the PRRC location requirements, ensuring seamless compliance with EU regulations and guidance. Whether you operate from within or outside the EU, we provide tailored solutions to meet your PRRC obligations effectively.

Person Responsible for Regulatory Compliance (PRRC)