November 2022
By Evangelia Manika, Associate
PRRC stands for person responsible for regulatory compliance.
In particular, PRRC is a qualified regulatory expert that is responsible, among others, for ensuring that 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. According to Article 15 of MDR and IVDR, manufacturers, authorized representatives and micro and small manufacturers must designate at least one person responsible for ensuring compliance to the MDR and/or IVDR. In particular, manufacturers shall have available within their organization at least one person responsible for regulatory compliance who possesses the requisite expertise in the field of medical devices i.e. four years of professional experience in regulatory affairs or in quality management systems relating to medical devices. In this case, the PRRC appointed would need to be an employee of the organization.
On the contrary, micro and small enterprises shall not be required to have the person responsible for regulatory compliance within their organization but shall have such person permanently and continuously at their disposal. Therefore, a micro or small enterprise may subcontract the responsibilities of a person responsible for regulatory compliance to a third party, so long as the qualification criteria are met. As for the authorized representatives, they shall have permanently and continuously at their disposal at least one person responsible for regulatory compliance who possesses the requisite expertise regarding the regulatory requirements for medical devices in the Union. Therefore, Authorized Representatives may also outsource their PRRC responsibilities to third parties, provided their subcontractors meet stated qualifications.
The role of PRRC is becoming more relevant than ever as it becomes clear that authorized representatives, due to their increased market surveillance responsibility, may be jointly and severally liable for defective and/or MDR/IVDR non-compliant products. An exception to the PRRC definition is products with valid MDD/AIMDD certificates issued until 26 May 2021 for MDD or after 26 May 2022 for IVDR, i.e. on the one hand for medical devices placed on the market from the date of application of the MDR until 26 May 2024 or on the other hand until 26 May 2022 for IVDR, in accordance with the transitional provisions of Article 120 of the MDR and Article 110 of the IVDR Regulation and the recent MDCG guidelines.
