PRRC – New role required by MDR
With coming into power of EU regulation 2017/745, a new role requirement is created for Manufacturers and Authorised representatives of medical devices. A wish for managing compliance with EU MDR resulted in creating the role of the person responsible for regulatory compliance (PRRC). The person responsible for regulatory compliance (PRRC) should possess the requisite expertise in the field of medical devices. Requisite expertise shall be demonstrated by either of the following qualifications (as defined in Article 15 of the EU regulation 2017/745):
- a diploma, certificate or other evidence of formal qualification, awarded on completion of a university degree or of a course of study recognized 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;
- four years of professional experience in regulatory affairs or in quality management systems relating to medical devices
What are the main responsibilities of PRRC?
The role of PRRC is defined in Article 15 of the EU regulation 2017/745 and it requires the following:
- 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;
- the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date;
- the post-market surveillance obligations are complied with in accordance with Article 10(10);
- the reporting obligations referred to in Articles 87 to 91 are fulfilled;
- in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued.
The responsibilities of PRRC are significant and set to ensure the regulatory compliance of the marketed medical device. According to Article 15 of the EU regulation 2017/745: The person responsible for regulatory compliance shall suffer no disadvantage within the manufacturer’s organization in relation to the proper fulfillment of his or her duties, regardless of whether or not they are employees of the organization.
What does it mean “within their organization”?
Medical devices Manufacturers and Authorised representatives should “have available within their organization… permanently and continuously at their disposal at least one person responsible for regulatory compliance” (as defined in Article 15 of the EU regulation 2017/745). According to interoperations of Competent Authority “within their organization” means to have person permanently employed in the company. The roles of the PRRC should be written in employees Job Descriptions together with the requirement that they have the qualifications listed in the MDR. We suggest documenting the PRRC role in Quality Manual and organization chart (showing suitable independence). The PRRC should have a key role in the “Strategy for Regulatory Compliance” procedure.
Outsourcing option for micro and small enterprises
Small and micro enterprises are defined as manufacturers with fewer than 50 full-time employees (globally) and under 10 million Euros in global sales revenue (not just EU). Manufacturers and authorized representative that fall in the above category are not required to have a “person responsible for regulatory compliance within their organization”. Micro and small enterprises are still required to have a “permanently and continuously at their disposal” person responsible for regulatory compliance but it can be outsourced.
Medisint can help you achieve regulatory compliance and continue your daily operations. By outsourcing the person responsible for regulatory compliance and all the connected obligation to Medisint you can be assured in regulatory compliance of marketed medical devices. Medisint will take over all of the obligations of the person responsible for regulatory compliance and be “permanently and continuously at your disposal”. You will be able to focus on the main objective of your business and market medical devices knowing that you have a reliable partner for regulatory support.