[ARTICLE] PRRC responsibilities, qualification requirements & legal liability
The MDR and IVDR introduce the requirement for device manufacturers and authorized representatives to appoint a Person Responsible for Regulatory Compliance (PRRC). The PRRC responsibilities, functions, and required qualifications are defined in Article 15 of the MDR and IVDR. Nonetheless, the question of the legal liability of the PRRC is not formally addressed.
PRRC candidates are often reluctant to accept the function due to the fear of the consequences this potential liability could incur. This article aims to discuss PRRC qualification requirements and PRRC function, as well as to clarify the legal liability of PRRCs.
PRRC responsibilities
As per MDR/IVDR Article 15, the PRRC is responsible for ensuring that the conformity of the devices is appropriately checked, in accordance with the manufacturer’s quality management system, before a device is released. He/she must also make sure the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date.
Moreover, the PRRC shall ensure the post-market surveillance obligations are complied with in accordance with Article 10(10) and that the reporting obligations referred to in Articles 87 to 91 are fulfilled. Finally, in the case of investigational devices, the PRRC is responsible for ensuring the statement referred to in Section 4.1 of Chapter II of MDR Annex XV, or section 4.1 of Chapter I of IVDR Annex XIV, is issued (MDR/IVDR Article 15(3)(a-e)).
the responsibilities of the PRRC and clear rules in case of diverging opinion with the managing entity should be explicitly defined, for example in the PRRC job description, as to prevent any potential conflict of interest and ensure the PRRC is enabled with the required authority to carry out his/her function in accordance with the applicable Regulations
PRRC qualification requirements
The required expertise for one to be eligible for a PRRC role is detailed in Article 15(1).
The PRRC must either hold a university diploma or a certificate recognized as equivalent by the Member State concerned in the field of law, medicine, pharmacy, engineering or another relevant scientific discipline, in addition to at least one year of professional experience in the area of regulatory affairs or in quality management systems relating to medical devices; or alternatively possess at least four years of professional experience in regulatory affairs or in quality management systems related to medical devices.
In the case of custom-made devices, the PRRC may demonstrate the requisite expertise by having at least 2 years of experience in the relevant field of manufacturing.
PRRC in micro and small enterprises
Manufacturers are required to have a PRRC within their organization.
An exception is nonetheless made for micro and small enterprises, in which case the PRRC may be part of an external organization provided the permanent and continuous availability of that party is ensured through a contract.
Micro and small enterprises are defined as organizations that employ fewer than 50 persons and have an annual turnover and/or annual balance sheet does not exceed EUR 10 million (Commission Recommendation 2003/361/EC Article 2(2-3)).
The responsibilities of the PRRC may be distributed between two or more individuals within the organization, or, in the case of micro and small enterprises, shared between internal and outsourced resources. The MDCG 2019-7 guidance on Article 15 nevertheless clarifies that in all cases a close linkage between the PRRC and the product realization activities is incurred. Thus, the PRRC is expected to be located in close geographic proximity with the product realization site.
What about PRRC liability?
The question of PRRC liability is however much less clearly defined in the MDR. Generally speaking, an employee may not be held liable for ordinary negligence. The liability stands with the economic operator, and should be covered by the organization’s liability insurance.
Nonetheless, in the event of gross negligence or when intent can be demonstrated, the organization may resort to recourse, including legal action, against the employee. Resort to recourse may also come from other parties such as patients, association of patients or healthcare professionals if the device has led to a serious injury or death of the patient (Directive 85/374/EEC).
Personal coverage for the PRRC may be provided by including the PRRC in the organization’s Directors’ and Officers’ (D&O) liability insurance policy. In all cases, the responsibilities of the PRRC and clear rules in case of diverging opinion with the managing entity should be explicitly defined, for example in the PRRC job description, as to prevent any potential conflict of interest and ensure the PRRC has the required authority to carry out his/her function in accordance with the applicable Regulations.
In Belgium for instance (...) economic operators whom fail to comply with their obligations under MDR Article 15 shall face a criminal fine of up to EUR 50’000 and/or imprisonment of one month to one year.
The MDR and IVDR stipulate that the Member States shall law down the rules on penalties applicable for the infringement of the provisions of the Regulation, and thus on a national level fines and/or penal provisions are to be expected for organizations who do not meet the PRRC requirements. In Belgium for instance, the Act on Medical devices defines in Articles 71(6) and 68 that economic operators whom fail to comply with their obligations under MDR Article 15 shall face a criminal fine of up to EUR 50’000 and/or imprisonment of one month to one year.
This article was written by Dr Jérôme Randall.
How Medidee can help
Whether you are an organization seeking to complete an employee’s training to reach the minimal PRRC qualifications defined in the MDR, or a micro or small enterprise seeking to outsource PRRC functions, Medidee will support you through our recognized CARAQA training network or in providing external qualified regulatory affairs experts to fulfil this role. Contact us now!
