Person Responsible for Regulatory Compliance

The new PRRC role and its requirements under the EU MDR

There are numerous new requirements under the EU Medical Device Regulation (EU MDR) and EU In Vitro Diagnostic Device Regulation (EU IVDR). The need to establish a new role has been seen by numerous medical device manufacturers and has resulted in the creation of the PRRC (Person Responsible for Regulatory Compliance) for the EU MDR and EU IVDR.?

This paper shall address the most important queries regarding the PRRC, their duties, and what medical device businesses might anticipate from the new standards

What is a PRRC?

The Person Responsible for Regulatory Compliance, or PRRC, is a new EU MDR and IVDR requirement in place to make sure medical device manufacturers have a qualified regulatory expert.

Manufacturers and authorised representatives are required to have at least one PRRC in order to comply with Article 15 of the EU MDR and EU IVDR. This rule will take effect for MDR on May 26, 2021, and IVDR on May 26, 2022.

Who needs a PRRC?

A PRRC is required for all manufacturers and authorised EU representatives. Manufacturers must ensure that the person they have designated as their EU authorised representative meets the PRRC requirements listed in Article 15 of the MDR and IVDR. Where a company consists of more than one legal manufacturer, each legal manufacturer must appoint its own PRRC.

The PRRC's new role, according to the MDCG 2019-07 document, is to make sure that mandatory manufacturing and post-market surveillance and vigilance operations are effectively carried out. A manufacturer's PRRC and EU authorised representative cannot be the same individual. Therefore, if a micro or small organisation hires a third-party expert to handle their PRRC, their authorised representative cannot outsource to the same expert.

It should be highlighted at this point 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 requisite expertise in the field of medical devices. This is defined as someone having either:

(a)??????a diploma, certificate or other evidence of formal qualification, awarded on completion of a university degree or of a 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, it is also necessary to demonstrate professional expertise in quality management systems or medical device regulatory matters that were acquired in the EU. A job contract, organisation chart, training records, or document releases must be used to support a qualification based on professional experience.

The EU Medical Device Coordination Group clarifies Article 15 of the MDCG 2019-7. Regarding the necessary qualifications, the guideline specifies that any qualifications gained outside the EU must have been recognised as being the equivalent to the corresponding EU qualification by an EU Member State in order to satisfy the requirements of Article 15.

?What are the responsibilities of a PRRC under the MDR?

Article 15(3) of the EU MDR outlines the requirements and responsibilities of the PRRC. 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.

The MDR's Article 11(3) requires a PRRC of an authorised representative to ensure compliance with the EU approved representative's requirements. The MDR also demands that the PRRC's name and contact details be present in the EUDAMED database. It should also be noted that whilst the PRRC is in charge of ensuring compliance to the MDR, they are 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, as 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 since, any company with more than 50 employees and a yearly revenue of at least EUR 10 million must have a PRRC who satisfies the requirements.

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. If the criteria are met, their PRRC does not have to be a direct employee; it could be an outside specialist. This is contingent on the appointed PRRC 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.

It is important to 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 an external PRRC that is constantly accessible, along with a designated representative in case of absences. The PRRC 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 is required to 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.

The role of the PRRC, which will be audited, must be incorporated into the quality management system (ISO 13485).

What are the liability implications?

The MDR/IVDR prohibits discrimination against the PRRC because of their obligations, although it makes no mention of the PRRC's liability. The MDCG 2019-7 does not offer any advice in this regard either. To make sure 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 utilise 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, as well as how severely and under what circumstances (gross negligence, serious fault, fraud) a PRRC may be penalised for failing to uphold its obligations under Article 15 (3).

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. Because the position entails a great deal of responsibility and personal accountability, TEAM-PRRC will analyse advice and advocate for PRRC professionals' protection.

CLIN-r+ recommendations

A PRRC is required to be chosen by manufacturers and authorised representatives. They must ensure that any employee or outside expert (if applicable) can provide sufficient proof of their suitability for the position.

Considering all the necessary factors, make sure your contract with the PRRC is clear and fit for purpose given the 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!