PRRC Responsibilities
As part of the EU MDR [1] a new role has been created, known as the Person Responsible for Regulatory Compliance [2] (PRRC). The Recitals to the EU MDR provide context to this new and important role…
“It should be ensured that supervision and control of the manufacture of devices, and the post-market surveillance and vigilance activities concerning them, are carried out within the manufacturer's organization by a person responsible for regulatory compliance who fulfills minimum conditions of qualification” [3].
The PRRC role should be considered as an active role with significant responsibilities of supervision and control, as further described in Article 15 [4], and summarized herein, to ensure:
Conformity of the devices are verified prior to production release, in accordance with the Quality Management System (QMS) under which the devices are manufactured;
Post-Market Surveillance (PMS) of ongoing device safety and maintenance of the appropriate/risk benefit balance
Technical documentation is actively maintained;
The Declaration of Conformity is actively maintained;
Vigilance reporting requirements are met for:
Serious incidents
Field Safety Corrective Actions (FSCA)
Trend Reporting
Analysis of serious incidents
Analysis of FSCA
Analysis of vigilance data
While the new regulation mandates the PRRC position and defines significant responsibilities, it does not define who should be appointed as the PRRC within a medical device manufacturer. Additional information about the role is that the appointed person(s):
Must possess the qualifications described within EU MDR, Article 15
Must be permanently and continuously at the disposal of the manufacturer
May be a number of persons who are jointly responsible for regulatory compliance
Shall suffer no disadvantage within the manufacturer’s organization in relation to the proper fulfillment of duties , regardless of whether or not they are employees of the organization or contracted to it
There should be significant consideration given to how the organization will appoint a person(s) and fulfill all of these requirements. Clearly, the accountability for the PRRC responsibilities could be divided amongst several persons and they should be provided with the tools necessary to fulfill their obligations to the organizational stakeholders.
The Quality System(s) Management (QSM) solution is one such tool, provided by Mgmt-Ctrl, that offers a risk-based approach to measuring, managing and improving product and process quality in support of the PRRC to ensure the new requirements are met for the following EU MDR elements:
Post-Market Surveillance (PMS) | MDR, Article 83
A comprehensive system to gather experience from the use of devices.
Post-Market Surveillance Plan (PMS Plan) | MDR, Article 84
A plan that describes the implementation of the PMS system for collecting information and characterizing the safety and performance of the device, or family of devices, and the methods and processes to assess the collected information.
Post-Market Surveillance Report (PMS Report) | MDR, Article 85
A report that summarizes the results and conclusions of analysis of the PMS data.
Periodic Safety Update Report (PSUR) | MDR, Article 86
A report that summarizes the results and conclusions of analysis of the PMS data with usage data.
FSCA Analysis | MDR, Article 89
An analysis of serious incidents and field safety corrective actions.
FSCA Vigilance | MDR, Article 87
Reporting of serious incidents and field safety corrective actions.
Trend Reporting | MDR, Article 88
Reporting of product and process quality trends.
Technical Documentation for Post-Market Surveillance | MDR, Annex III
Information characterizing the safety and performance of a device.
The Quality System(s) Management (QSM) solution is a strategic plan, and associated processes, that provide the capability to ensure the ‘quality’ of the Quality Management System (QMS). Such a plan is especially relevant when considering Article 10 [5], within the EU MDR…
… manufacturers of devices … shall establish, document, implement, maintain, keep up to date and continually improve a quality management system that shall ensure compliance with this regulation in the most effective manner.
Quality Management System (QMS)…
– covers all parts and elements of a manufacturer’s organization dealing with the quality of processes, procedures and devices.
– governs the structure, responsibilities, procedures, processes and management resources to achieve compliance with this regulation.
Remembering that the PRRC is responsible for ensuring the conformity of the devices are verified prior to production release, and understanding the manufacturer is responsible to facilitate the provision of all the information and documentation necessary to demonstrate the conformity of the device [6], it is recommended that organization’s consideration of the PRRC role include the following:
PRRC responsibilities should be divided amongst multiple qualified individuals;
These persons, appointed to ensure the fulfillment of PRRC responsibilities, should report directly to the Chief Quality Officer (CQO).
In addition to the appointment of the employees designated to fulfill PRRC responsibilities, consideration should be given to the utilization of outside consultative resources, contracted either full time or part time in support of the persons appointed to fulfill the PRRC responsibilities, as required.
Organizations with more than one legal manufacturer under the parent company should ensure that each legal manufacturer, and/or manufacturing location, has its own PRRC.
Mgmt-Ctrl is capable of providing Quality System(s) Management support to designated Persons Responsible for Regulatory Compliance (PRRC) through the provision of our strategic Quality System(s) Management (QSM) solution, and associated processes. This occurs in conjunction with qualified Quality System Managers who can directly facilitate the ongoing measurement, monitoring, reporting and review of product and process ‘quality’, using their expertise and understanding of the QSM solution. Please contact us at info@Mgmt-Ctrl.com to learn more about the Quality System(s) Management (QSM) solution.
[1] (EU) 2017/745 of the European Parliament and of the Council, 117 Official Journal of the European Union 1 (Apr. 5, 2017) [hereinafter EU MDR]
[2] EU MDR, Article 15
[3] EU MDR, Recitals ¶ 34
[4] EU MDR, Article 15.3 (a- e) at 29
[5] EU MDR, Article 10 – General Obligations of the Manufacturer
[6] EU MDR, Article 10 (14)