PRRC is an acronym that stands for the person responsible for regulatory compliance. It is one of the new requirements of the European Union’s Medical Device Regulation (MDR) & In-Vitro Diagnostic Medical Device Regulation (IVDMDR) (IVDR). Its goal is to ensure that businesses have access to a qualified regulatory expert.
Article 15 of the EU MDR & EU IVDR requires manufacturers (and authorized representatives) to have at least a person responsible for regulatory compliance on staff to ensure the company is in complies with the MDR/IVDR. This requirement is mandatory as of the effective date of the respective EU Regulation, which is May 26, 202, for the MDR and May 26, 2022, for the IVDR.
What is PRRC?
PRRC is an acronym for “Person Responsible for Regulatory Compliance”. The EUMDR introduces new requirements for medical device manufacturers and clarifies the roles of PRRC. According to the new EU MDR regulation, which went into effect on May 26, 2021, medical device manufacturers must have a PRRC to ensure regulatory compliance. PRRCs play critical roles and responsibilities in the establishment of medical device manufacturing plants.
The PRRCs are the authorized individuals who must have specific qualifications and experience. The EU has published new rules and regulations for medical device manufacturers, and these companies or organizations should have Person Responsible for Regulatory Compliance (PRRC) with them to investigate regulations and policies. PRRC is in charge of regulatory compliance. Article 15(1) of the MDR and IVDR outlines some specific requirements for PRRC. If a medical device manufacturer wants to sell or supply their device in the European Union, they must have at least one Person Responsible for Regulatory Compliance (PRRC) on site.
Who Can Be Person Responsible For Regulatory Compliance (PRRC)?
The Person Responsible for Regulatory Compliance (PRRC) can be any person who has the necessary expertise in the field of medical devices, as demonstrated by the qualifications listed below.
- The individual must have a Diploma or University Degree in Law, Medicine, Pharmacy, Engineering, or another relevant discipline recognized by the member state, as well as at least one year of experience in Medical Device Quality Management.
Or
- Four years of professional experience in regulatory affairs or Quality Management systems for Medical Devices.
If you are a manufacturer of custom-made devices, you may demonstrate the necessary expertise by having at least two years of professional experience in a relevant field of manufacturing, subject to national provisions regarding professional qualifications. If a manufacturer does not have someone who meets the above requirements, they can:
- Hire a new employee to fill this role.
- Hire a consultant for a set period while simultaneously training your current employee.
Who Needs A Person Responsible For Regulatory Compliance (PRRC)?
A PRRC is required for all manufacturers and EU-authorized representatives. Manufacturers must confirm that their EU-authorized representative has appointed someone who satisfies the Person Responsible for Regulatory Compliance (PRRC) qualifications outlined in Article 15. If a company is made up of more than one legal manufacturer, each one must appoint its PRRC.
According to the MDCG 2019-07 document, the PRRC’s new role adds a level of scrutiny and ensures that the mandatory activities related to manufacturing supervision and control, as well as post-market surveillance and vigilance, are carried out appropriately. To effectively achieve this additional level, one person cannot serve as both the Person Responsible for Regulatory Compliance (PRRC) for a manufacturer outside the EU and the company’s EU-authorized representative. In this manner, if a micro/small business outsources its PRRC to an external organization, the company’s authorized representative cannot outsource their Person Responsible for Regulatory Compliance (PRRC) to the same outside expert.
Can A Company Have More Than One PRRC?
Companies are not limited to only one Person Responsible for Regulatory Compliance (PRRC), and responsibilities can be assigned to multiple people as long as the qualification requirements are met and the distribution of respective areas of responsibility is documented in writing (Article 15[4]). If the responsibilities are divided among several people, make certain that all responsibilities are covered.
Appointment of Person Responsible For Regulatory Compliance (PRRC)
The PRRC is appointed in the same way that your management representative is. You must create and sign an agreement with the Person Responsible for Regulatory Compliance (PRRC) that includes the following information:
- Purpose
- Scope
- Qualification Requirement
- PRRC Roles And Responsibilities
- Any Additional Roles And Responsibilities
- The PRRC And Company Head’s Signature and Date.
The manufacturer must ensure that Person Responsible for Regulatory Compliance (PRRC) is not penalized within the manufacturer’s organization for performing his or her duties properly, regardless of whether or not they are an employee of the organization. The manufacturer should be aware that only a qualified representative can act as Person Responsible for Regulatory Compliance (PRRC).
Importance of Identifying PRRC
Identifying the PRRC for your organization is a critical requirement that applies to the European Union and is a core area of responsibility for a person or people under the medical device regulation, also known as the In vitro device regulation. The decision to appoint the PRRC is also influenced by the size of the organization. Under the new EU MDR, this is a mandatory requirement for any CE Marking.
The object of this identification is to have a qualified regulatory expert who is responsible directly for manufacturing as well as market surveillance and reporting systems to ensure that the company meets European Union requirements. Companies are not limited to only one PRRC, and responsibilities can be assigned to multiple people as long as the qualification requirements are met & the distribution of the specific areas of responsibility is documented. If the responsibilities are divided among several people, make certain that all responsibilities are covered.
The Regulations express a clear desire to add another level of scrutiny to the supervision and control of medical device manufacturing, as well as relevant post-market surveillance and vigilance activities. As a result, identifying the PRRC role is a sole position from the European Union Authorized Representative. The importance of the MDR and IVDR identifying the PRRC role extends beyond the role of a safety officer. MDCG 2019-7 provides PRRC with prescriptive guidance on qualification and responsibility. The manufacturer must find someone who can fill this critical role.
The PRRC should be identified if he is in charge of the technical documentation EU Declaration of Conformity (drawn up and kept up to date), post-market surveillance obligations, and checking the conformity of devices before they are released (according to the QMS). Each legal manufacturer is required to have its PRRC. If the manufacturer is located in the EU, the PRRC must be close to it also. Both must be closer to each other.
Responsibilities of A PRRC under the MDR
The PRRC is responsible for ensuring the followings according to article 15(3), EU MDR:
(a) Prior to the release of a device, the conformity of the devices should be checked properly in the line with the quality management system under which the devices are manufactured;
(b) The technical documentation & the EU declaration of conformity are to be prepared and kept up to date; and
(c) The post-market surveillance obligations are met following Article 10(10).
(d) The reporting obligations referred to in Articles 87-91 are met (NOTE: This refers to Vigilance reporting, which includes serious incidents, field safety corrective action, and incident trend reporting).
(e) The statement referred to in Section 4.1 of Chapter II of Annex XV is issued in the case of investigational devices. NOTE: This is the statement confirming that the investigational device complies with the General Safety & Performance Requirements in Annex I of the EU Medical Device Rules, except those relating to aspects covered by the clinical investigation, and that precautions are taken to safeguard the subject’s health & safety.
The responsibility of a PRRC of an authorized representative (who is subject to the same qualification requirements as a PRRC of a manufacturer) under the MDR is to ensure compliance with the requirements applicable to the EU authorized representative, as outlined in Article 11(3) of the Medical Device Rules.
The MDR requires the name and contact information of the designated person responsible for regulatory compliance to be entered into the EUDAMED database.
The MDR does not require the PRRC to perform all tasks and activities to ensure compliance with the requirements, but only those that fall under his/her responsibility.
Responsibilities of A PRRC under the IVDR
The PRRC is responsible for ensuring the followings according to article 15(3), EU IVDR:
(a) Prior to the release of a device, the conformity of the devices should be checked properly in the line with the quality management system under which the devices are manufactured;
(b) The technical documentation & the EU declaration of conformity are prepared and kept up to date;
(c) The post-market surveillance obligations are met per Article 10(9); and
(d) The reporting obligations referred to in Articles 82-86 are met (NOTE: This refers to Vigilance reporting, which includes serious incidents, field safety corrective action, and incident trend reporting).
(e) The statement referred to in Section 4.1 of Chapter II of Annex XV is issued in the instance of devices for performance studies intended to be used concerning interventional clinical performance studies/other performance studies involving risks for the subjects.
This is the statement confirming that the device meets the General Safety and Performance Requirements in Annex I of the EU IVDR, except for aspects covered by the clinical performance study & that precautions are taken to protect the subject’s health and safety.
The European Union Medical Device Coordination Group clarifies in its guidance document MDCG 2019-7[1], as it does for the MDR that the responsibilities of an EU-authorized representative’s PRRC are to ensure the fulfillment of the EU-authorized representative duties, as stated in the manufacturer’s mandate and accordance with Article 11(3) of the IVDR.
PRRC Outsourcing
Only companies with fewer than 50 employees and an annual turnover of less than EUR 10 million (defined as micro and small enterprises under Commission Recommendation 2003/361/EC) are permitted to outsource their PRRC to an outside expert, provided that the PRRC meets the qualification criteria and is permanently and continuously available to them.
It is vital to note that neither the MDR/IVDR nor the MDCG 2019-7 guidance document goes into detail about the practical implications of permanent and continuous availability. As a result, it is recommended that manufacturers and EU-authorized representatives interpret this requirement conservatively and that their external PRRC is reachable 24 hours a day, seven days a week & has an officially designated designee for absences. The contractual agreement with the Person Responsible for Regulatory Compliance (PRRC) should detail his or her permanent & continuous availability, as well as the qualification of the relevant person.
Because the person will be responsible for compliance with procedures, technical documentation, and post-market obligations, outsourcing the PRRC function necessitates appropriate agreements. An outsourced PRRC must be available at all times and integrated in such a way that all parties involved can meet the MDR/IVDR requirements.
In terms of PRRC location, the MDCG document specifies that a PRRC of manufacturers located in the European Union must also be located in the EU. This is because a permanent and continuous link between the PRRC and the manufacturing activities must be established.
Liabilities of the PRRC
While the MDR/IVDR states that the PRRC must not be discriminated against because of their duties, it does not go into detail about the person responsible for regulatory compliance’s potential liability. Neither does the MDCG recommendation (MDCG 2019-7). However, this information would be useful in ensuring that the PRRC doesn’t suffer any disadvantage in carrying out its duties and in structuring the mandate accordingly. While some of these points (such as liability limitations) can be included in employment contracts, national laws will have to clarify these points until an EU-wide provision is in place.
The question remains whether a violation of Article 15(3) will result in enforcement directed against the company/also against the PRRC & to what extent and under what circumstances (such as gross negligence, serious fault, or fraud) a PRRC can be punished for failing to carry out his responsibilities as outlined in Article 15(3).
Conclusion
TEAM-PRRC is a European non-profit organization formed to represent its members at the European Commission and the Medical Device Coordination Group. The association’s goal is to gain insight into and influence the PRRC role guidance that is being developed, as well as to promote understanding of the PRRC responsibilities. TEAM-PRRC will assist its members by analyzing available guidance and promoting greater security for the PRRC professionals themselves, as the role carries significant responsibility and potentially significant personal liability.
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How Has EU-MDR Affected CE Marking For Medical Devices?
