Guidance on Identifying the Person Responsible for Regulatory Compliance under MDR and IVDR

The EU Commission enforced the concept of the person responsible for regulatory compliance (PRRC) in the new guidelines for managing compliance with EU MDR and IVDR. It is imperative that the PRRC role is established and implemented by both the manufacturers and their respective authorized representatives (AR) who are about to place compliant medical devices on the market. The aim of the regulators was to reinforce the professionalism of both manufacturers and authorized representatives while increasing scrutiny and ensuring implementation of vigilance activities.

The following is the fourteenth in the series of EU MDR related blogs. To learn more about the EU MDR changes you can view some of the previous posts in the series:

• Medical Device Equivalence vs Demonstration of Equivalence
• Post-market Clinical Follow-up Requirements for EU MDR
• The New European Union MDR: Impact on Technical Files
• Low-risk Device Challenges
• Selecting and Working with your Notified Body
• Medical Devices with Ancillary Medicinal Substances
• Regulatory Challenges Writing EU MDR Compliant Clinical Evaluation Reports (CER)
• International Medical Device Regulators Forum (IMDRF) & Summary of Recent Changes to Clinical Evaluation Guidance
• Remote Medical Audits During COVID-19
• Celegence Webinar: Taking advantage of the EU MDR Delay in Uncertain Times
• Components of an Effective Post-Market Surveillance for Medical Devices
• Medical Device Labeling Changes & Challenges under EU MDR
• EU MDR Risk Management Requirements: From complex regulation to impactful change with the new ISO 14971

Article 15 of MDR 2017/745 states that:

“Manufacturers shall have available within their organisation at least one person responsible for regulatory compliance who possesses the requisite expertise in the field of medical devices.”

The requisite expertise of the PRRC is also detailed in the regulation and is applicable to manufacturers placing class I devices. However, micro and small enterprises (defined as an organization employing fewer than 50 staff and not exceeding EUR 10 million in annual turnover and/or annual balance sheet total) need not have such a person immediately in their organization, but a PRRC must be available at their disposal.

The PRRC is required to have minimum qualifications, that include:

• A diploma, certificate, or other evidence of formal qualification from a university recognized as equivalent by the concerned Member State in law, medicine, pharmacy, engineering, or another relevant scientific discipline, with at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices.
• Professional experience of at least four years in regulatory affairs or in quality management systems relating to medical devices
• Manufacturers of custom-made devices are to have at least two years of professional experience within a relevant field of manufacturing

The PRRC is responsible for ensuring:

• Conformity of the device to the manufacturer’s QMS prior to release
• Technical documentation and EU Declaration of Conformity (DOC) are up to date
• Post-market surveillance obligations follow Article 10(10)
• Reporting obligations referred to in Articles 87 to 91 are fulfilled
• The statement referred to in Section 4.1 of Chapter II of Annex XV is issued in the case of investigation devices

While the Regulations set out requirements on the qualification of the PRRC, and an overview of their responsibilities, the Medical Device Coordination Group (MDCG) published new guidance documents under the Medical Devices Regulation (MDR) and In Vitro Diagnostic Devices Regulation (IVDR). These requirements provide additional details that address certain ‘grey zones’ within the regulation, and clarifies the PRRC requirements for manufacturers and AR, notably that:

• Each legal manufacturer must have a PRRC at their disposal, and where organizations have more than one legal manufacturer within the group, each manufacturer must have their own PRRC, the guidance does not clarify if the same PRRC can act for multiple manufactures
• Manufacturers that are not established in the EU must have an AR in a Member State of the EU, who must also have a PRRC. The AR may also subcontract the responsibilities of the PRRC to a third party. One individual cannot be the PRRC for both the manufacturer and the AR, and in the case of a micro or small enterprise, the PRRC of the manufacturer and the PRRC of the AR cannot be from the same external organization
• In terms of location, the PRRC should be in the same place as the manufacturer or AR. Therefore, if a manufacturer is located outside the EU, the PRRC should also be located outside the EU. Manufacturers in the EU should likewise have a PRRC located inside the EU, as the AR will be in the EU, the PRRC will also be located inside the EU
• If the required qualifications of the PRRC were not obtained in the EU, they should be recognized by an EU Member State as equivalent to the EU corresponding qualification
• Professional experience of the PRRC in the regulatory affairs or in quality management systems (QMS) related to the medical device should be related to the EU requirements in the field
• The PRRC appointed should be an employee of the organization
• Micro or small enterprises may subcontract the responsibilities of the PRRC to a third party, provided the PRRC has the relevant qualifications and the manufacturer can demonstrate they are able to fulfil their legal obligations while using a third party who is not within the manufacturers’ organization

While the MDR allows the appointment of more than one PRRC, it would be ideal to split the responsibilities of the PRRC among different responsible persons in different departments, both within the company, or externally. Each appointed PRRC (including deputies) should have the qualifications as required by the regulation. Additionally, it is important for every PRRC to be registered in the EUDAMED database when it is available. As stated in the regulation, the PRRC will suffer no disadvantage within the manufacturer’s organization in relation to the proper fulfilment of his or her duties, regardless of whether they are employees of the organization.

Every stakeholder involved in medical device regulatory compliance is aware that the demands of the new EU MDR are far more complex than the MDD. Although the new requirements under the regulation can be challenging, the adjustments are manageable when tackled systematically. Based on the type and size of your organization, the requirements for a PRRC may vary. The importance of introducing the role of a PRRC by the MDR and IVDR goes beyond the role as that of a safety officer. While the EUMDR mandates to appoint a new figure in the organizational chart of an enterprise, has your organization considered how you will manage the role of the PRRC for regulatory compliance?