Who needs a PRRC and what the role covers

The role of the Person Responsible for Regulatory Compliance (PRRC) is central to ensuring adherence to the European Union's Medical Device Regulation (MDR (EU) 2017/745) and In Vitro Diagnostic Medical Device Regulation (IVDR (EU) 2017/746). This designated individual plays a critical part in maintaining the safety and performance of medical devices placed on the EU market, overseeing regulatory obligations for manufacturers and authorised representatives.

#Legal Basis and Scope: Who requires a PRRC?

The requirement for a PRRC is explicitly defined in both the MDR and IVDR. Under MDR Article 15 and IVDR Article 15, manufacturers and authorised representatives are mandated to have permanent and continuous access to a PRRC. This individual must possess the requisite expertise in the field of medical devices.

#Manufacturers

Manufacturers, regardless of their size, must appoint a PRRC. This includes manufacturers of custom-made devices. The PRRC for a manufacturer must reside within the European Union if the manufacturer is established outside the EU, in which case the authorised representative’s PRRC will primarily cover the EU-based regulatory tasks. However, if the manufacturer is established within the EU, their PRRC can be an employee or an external expert. Small and medium-sized enterprises (SMEs) are subject to specific provisions under MDR Article 15(3) and IVDR Article 15(3), allowing them to contract an external PRRC.

#Authorised Representatives

Authorised representatives (ARs) are also required to appoint a PRRC. This is specified in MDR Article 15(4) and IVDR Article 15(4). The AR's PRRC must reside in the European Union.

#Other Economic Operators: Distributors and Importers

Distributors and importers are not legally mandated to appoint a PRRC under the MDR or IVDR. Their obligations are distinct and are detailed in MDR Article 14 for distributors and MDR Article 13 for importers (and corresponding articles in the IVDR).

Despite not requiring a PRRC, distributors and importers must ensure they have robust systems and qualified personnel in place to meet their specific regulatory duties. This includes verifying device conformity, maintaining traceability, and cooperating with competent authorities. For a detailed understanding of these responsibilities, readers may refer to Importer Obligations for Medical Devices Under MDR Article 13 and Distributor Obligations: Verifying Medical Devices Under MDR Article 14.

#Qualifications and Expertise of the PRRC

MDR Article 15(1) and IVDR Article 15(1) specify the qualifications for a PRRC. The individual must possess expertise in the field of medical devices. This expertise is demonstrated by either:

• A diploma, certificate, or other evidence of formal qualification in a relevant scientific or technical discipline, successfully completed a university degree or an equivalent course of study, and at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices.
• Four years of professional experience in regulatory affairs or in quality management systems relating to medical devices, without the formal qualification mentioned above.

For manufacturers of custom-made devices, the PRRC qualifications are slightly adapted under MDR Article 15(2) and IVDR Article 15(2), requiring proof of professional experience in manufacturing custom-made devices.

#Key Responsibilities of the PRRC

MDR Article 15(3) and IVDR Article 15(3) outline the core responsibilities of the PRRC for manufacturers. These duties ensure that devices comply with regulatory requirements throughout their lifecycle. The PRRC is responsible for at least:

• Conformity of devices: Verifying that the conformity of devices is appropriately checked in accordance with the quality management system under which the devices are manufactured before a device is released.
• Technical documentation and EU declaration of conformity: Ensuring that the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date.
• Post-market surveillance: Ensuring that the post-market surveillance obligations are complied with in accordance with MDR Article 10(10) and IVDR Article 10(10).
• Reporting obligations: Ensuring that the reporting obligations in accordance with MDR Articles 87 to 91 and IVDR Articles 82 to 86 are fulfilled.
• Clinical investigations: For investigational devices, ensuring that the declaration referred to in MDR Annex XV Chapter II Section 4.1 or IVDR Annex XIV Chapter I Section 4.1 has been issued.

For authorised representatives, the PRRC's responsibilities mirror those listed above, ensuring the authorised representative's obligations under MDR Article 11(3) and IVDR Article 11(3) are met.

#Overview of PRRC Requirements

#Independence and Liability

The PRRC must maintain independence within the organisation to effectively carry out their duties without undue influence. They shall not suffer any disadvantage in relation to the proper fulfilment of their duties, irrespective of whether they are an employee or an external contractor. This protection is enshrined in MDR Article 15(6) and IVDR Article 15(6).

Notably, the PRRC's liability extends to ensuring compliance with the regulations. They are directly accountable for fulfilling their responsibilities. This is a significant aspect of the role, emphasising the need for competence and diligence. Any liability of the PRRC is without prejudice to the responsibilities of the manufacturer or the authorised representative as specified in the MDR or IVDR.

#Common mistakes in practice

• Lack of demonstrable qualifications: Appointing a PRRC without adequately documented evidence of their formal qualification or professional experience as required by MDR Article 15(1) or IVDR Article 15(1).
• Insufficient independence: The PRRC being unable to act independently due to internal company structures or pressures, undermining their ability to ensure compliance.
• Failure to define responsibilities clearly: The specific duties of the PRRC are not clearly assigned or understood within the organisation, leading to gaps in regulatory oversight.
• Non-EU PRRC for EU-based AR: An authorised representative established in the EU appoints a PRRC who resides outside the EU, which contradicts MDR Article 15(4) and IVDR Article 15(4).
• Overlooking ongoing training: Not providing the PRRC with continuous professional development to stay current with evolving regulatory requirements and guidance.
• PRRC without backup: Failure to ensure continuity of the PRRC function, for example, during absences or staff turnover, which could leave the organisation without a continuous compliance oversight.

#EUDAMED and the PRRC

The EUDAMED database plays an increasingly vital role in medical device regulation. While the PRRC does not directly manage EUDAMED entries for all modules, their oversight function ensures that data submitted to EUDAMED is accurate and compliant with the regulations. For instance, the PRRC would be responsible for ensuring that the manufacturer's or authorised representative's information, including details about themselves, is correctly registered. The PRRC's role is critical in validating the integrity of information that ultimately feeds into EUDAMED.

Rules around the EUDAMED modules have changed in stages. The reader should confirm the current status and scope with their national competent authority. The EUDAMED AI platform can assist economic operators in navigating the complexities of data management within this system, helping to ensure that the information required by the PRRC for their compliance tasks is readily available and correctly structured, such as facilitating submission of device data or adverse event reports. More information on how the platform can assist with regulatory compliance can be found at: https://eudamedai.com/#funkcije.

This material is for information only and is not legal advice. For binding interpretation consult your national competent authority.