Person Responsible for Regulatory Compliance (PRRC)
The new PRRC role and its requirements under the EU MDR
Under the EU MDR and EU IVDR, there are many new requirements. Many medical device manufacturers recognise the need to establish a new role. This has led to the creation of the Person Responsible for Regulatory Compliance for the EU MDR and EU IVDR.
This paper addresses the most important queries regarding the PRRC. Including their duties and what medical device businesses could anticipate from the new standards.
What is a PRRC?
The Person Responsible for Regulatory Compliance is a new EU MDR and IVDR requirement. This is to ensure that medical device manufacturers have a qualified regulatory expert.
Manufacturers and authorised representatives must have at least one PRRC to comply with Article 15 of the EU MDR/IVDR. This rule took effect for MDR on May 26, 2021, and IVDR on May 26, 2022.
Who needs a PRRC?
All manufacturers and authorised EU representatives require a PRRC. Manufacturers must ensure that the person they have designated as their EU authorised representative meets the requirements. Article 15 lists these. Where a company has more than one legal manufacturer, each legal manufacturer must appoint its own PRRC.
MDCG 2019-07 specifies that the PRRC ensures that mandated manufacturing, post-market surveillance, and vigilance operations are carried out effectively. A manufacturer’s PRRC and EU authorised representative cannot be the same individual. So if a micro / small organisation hires a third-party PRRC expert, their authorised representative cannot outsource to the same expert.
We should highlight that this applies to all companies that produce medical devices, including Class I devices.
Who can be a PRRC?
Article 15(1) of the MDR/IVDR states that the PRRC must possess the expertise in medical devices. They define this as someone having either:
(a) a diploma, certificate or other evidence of formal qualification, awarded on completion of a university degree or course of study recognised as equivalent by the Member State concerned, in law, medicine, pharmacy, engineering or another relevant scientific discipline, and at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices;
or:
(b) four years of professional experience in regulatory affairs or in quality management systems relating to medical devices.
A diploma or certificate is the simplest way to prove formal qualification. However, EU-acquired quality management system or medical device regulatory experience is required. A professional experience-based qualification requires support from an employment contract, organisation chart, training records, or document releases.
The EU Medical Device Coordination Group clarifies Article 15 of the MDCG 2019-7. To meet Article 15 requirements, the guideline must recognise non-EU qualifications as equivalent to EU qualifications from EU Member States.
What are the responsibilities of a PRRC under the MDR?
Article 15(3) of the EU MDR outlines requirements and responsibilities. The PRRC of a manufacturer is responsible for ensuring that:
(a) the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released;
(b) the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date;
(c) the post-market surveillance obligations are complied with in accordance with Article 10(10);
(d) the reporting obligations referred to in Articles 87 to 91 are fulfilled; NOTE: This refers to Vigilance reporting, i.e. serious incident, field safety corrective action, and incident trend reporting).
(e) In the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued. NOTE: This statement confirms that the investigational device meets the General Safety and Performance Requirements in Annex I of the EU MDR, except those that relate to the clinical investigation, and that precautions are taken to protect the subject’s health and safety.
Article 11(3) of the MDR requires an authorised representative’s PRRC to ensure EU approved representative compliance. The MDR also demands that the PRRC’s name and contact details be present in the EUDAMED database. Note that the PRRC ensures MDR compliance, but is not required to fulfil all tasks and activities themselves.
What are the responsibilities of a PRRC under the IVDR?
As per Article 15(3) of the EU IVDR, the PRRC is responsible for ensuring that:
(a) the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released;
(b) the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date;
(c) the post-market surveillance obligations are complied with in accordance with Article 10(9);
(d) the reporting obligations referred to in Articles 82 to 86 are fulfilled; NOTE: This refers to Vigilance reporting, i.e. serious incident, field safety corrective action, and incident trend reporting).
(e) In the case of devices for performance studies intended to be used in the context of interventional clinical performance studies or other performance studies involving risks for the subjects, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued. NOTE: This statement confirms that the investigational device meets the General Safety and Performance Requirements in Annex I of the EU IVDR, except those that relate to the clinical investigation, and that precautions are taken to protect the subject’s health and safety.
As with the MDR, the EU Medical Device Coordination Group clarifies in its guidance document MDCG 2019-7 that the PRRC of an EU authorised representative must ensure the fulfilment of its duties. These are stipulated in the manufacturer’s mandate and in accordance with Article 11(3) of the IVDR.
Does the PRRC need to be a company employee?
The size and revenue of a manufacturer is key here. Any manufacturer with more than 50 employees and EUR 10 million in revenue must have a compliant PRRC.
However, a business can outsource this position if:
- It has fewer than 50 employees,
- a yearly revenue of less than 10 million euros,
- and otherwise meets the criteria for micro/small companies as set down in Commission Recommendation 2003/361/EC.
To meet criteria, their PRRC does not have to be a direct employee; it could be an outside specialist. This is contingent on the appointed person meeting the requirements and remaining permanently and constantly accessible to the business.
In the case of the PRRC being outsourced, they must comply with post-market obligations, technical documentation, and procedural requirements. To meet MDR/IVDR requirements for all parties, an outsourced PRRC needs to be integrated and accessible around the clock.
Note that the MDCG 2019-7 and the MDR/IVDR do not discuss the practical implications of permanent and continuous availability. Therefore, manufacturers and EU authorised agents must be aware of this obligation and maintain a constantly accessible external PRRC. A designated representative must also be in place in case of absences. The contract should include information about the individual’s ongoing qualification and availability.
Where does the PRRC need to be located?
According to the MDCG document, a PRRC for a manufacturer based in the EU must be in the EU. A manufacturer outside the EU must have a PRRC based outside the EU. The PRRC and all activities related to manufacturing must be permanently and continuously linked.
You must integrate the role of the PRRC into the quality management system (ISO 13485) and audited.
What are the liability implications?
The MDR/IVDR prohibits discrimination against the PRRC because of their obligations, although it does not mention the PRRC’s liability. The MDCG 2019-7 does not offer any advice in this regard. To ensure that the PRRC does not suffer any consequences for doing its duties, this information would be helpful. National legislation will need to be used to explain some of these features until an EU-wide rule is in place. We advise PPRCs to use employment contracts to provide these details, including limitation of liability.
It is still unclear whether a breach of Article 15(3) would result in enforcement against the corporation or the PRRC. They could also penalise a PRRC for failing to uphold their obligations under Article 15 (3). Although it is also unclear how severely and under what circumstances (gross negligence, serious fault, fraud).
As a non-profit organisation, TEAM-PRRC represents its members before the European Commission and the Medical Device Coordination Group. The organisation aims to improve understanding of PRRC obligations and influence PRRC advice. The PRRC position requires a lot of responsibility and personal accountability. Therefore, TEAM-PRRC will analyse advice and advocate for PRRC professionals’ protection.
CLIN-r+ recommendations
Manufacturers and authorised representatives must choose a PRRC. They must ensure that any employee (or outside expert) can provide sufficient proof of their suitability for the position.
Consider all the necessary factors and ensure your contract with the PRRC is clear and fit for purpose. There are ambiguities surrounding personal liability and the enforcement of the role.
We hope the information in this document helps answer your questions regarding the role and responsibilities of a PRRC. Should you have any questions or need professional assistance, CLIN-r+ has a wealth of experience to call upon. Get in touch!
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