Key2Compliance Coordinating manager for PRRC explains what you need to know about the new required role of Person Responsible for Regulatory Compliance
The new medical device regulations MDR and IVDR have introduced a new role: Person Responsible for Regulatory Compliance (PRRC). According to Article 15 of MDR and IVDR, manufacturers of medical devices are now required to have a designated person who will be responsible for regulatory compliance (PRRC), and who can ensure that all post-market surveillance and obligations are met in accordance with Article 83. What does this mean for the manufacturers of medical devices?
Dalia Rhman is the Coordinating Manager for PRRC at Key2Compliance. She explains the new role, and how she and the team at Key2Compliance can help manufacturers of medical devices meet the regulations and bring successful products to market.
This is what PRRC means for manufacturers of medical devices
With the introduction of the new role of PRRC, Article 15 at Medical Device Regulation (MDR 2017/745) states that manufacturers shall have at least one person responsible for regulatory compliance who possesses the requisite expertise in the field of medical devices.
- A) A diploma, certificate, or other evidence of formal qualification, awarded on completion of a university degree or of a course of study recognised 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.
- B) This requisite expertise shall be demonstrated by either evidence of formal qualification, or at least four years of professional experience in regulatory affairs or in quality-management systems relating to medical devices.
Dalia Rhman certainly meets those qualifications, holding a master’s degree in Biomedicine, and, in addition, has good work experiences in diagnostics of cancer, genetic, and rheumatological diseases. She has a solid six years of work experience in the field of life science and is today a QA/RA consultant at Key2Compliance, acting as project manager helping medical device companies with the medical device regulatory requirements. Besides this, she is now also responsible for the Key2Compliance PRRC process to coordinate the PRRC team. Key2Compliance has several consultants who act as PRRCs for various clients. All Key2Compliance consultants have an equivalent background and experience to Dalia’s and fully meet the PRRC requirements in both MDR and IVDR companies.
Dalia explains her new PRRC role like this: “PRRC takes care of regulatory affairs and compliance. Most probably starting during development, the PRRC is responsible:
Within regulatory affairs:
- Make sure that the conformity of the devices is checked before a device is released.
- The technical documentation and the EU declaration of conformity are drawn up and current.
- The post-market surveillance obligations are complied with in accordance with Article 15 at MDR 2017/745.
- The PRRC is also responsible for ensuring that the company fulfils its reporting obligations.”
On the compliance side:
- Conformity of the manufactured product to the Quality Management System.
- The compliance and effectiveness of internal processes leading to a product.
- The applicability of international standards and their current status.
- Compliance of external processes, including potentially sourcing and external manufacturing.”
A PRRC is needed for every manufacturer of medical devices or in-vitro diagnostics and, in some cases, for authorized representatives and distributors as well.
Dalia is aware that many smaller manufacturers aren’t fully aware of what the PRRC role really means. Therefore, it is another part of her job to help customers to understand when they need PRRC, and why. “At Key2Compliance we usually combine QA/RA and PRRC, providing the PRRC when necessary for our clients. By agreement, smaller companies have the privilege to subcontract a PRRC who will be continuously and permanently at their disposal. We can take on that role in addition to our QA/RA work.”
The PRRC must always be available to ensure the documentations are kept-up to date and in case a deviation occurs. Every quarter, the PRRC reviews the documentation included in its area of responsibility, and afterward a quarterly report is written and approved by our PRRC team. Dalia explains this process: “the PRRC ensures that the documentations are done according to regulations and compliances are met. If necessary, the PRRC can also support when reporting to authorities or notified body”.
A simpler way for smaller manufacturers to meet the regulatory requirements
Dalia knows that it’s always a balance act for smaller companies both to follow the regulations and to produce products in a cost-effective way. “Our competence lies in providing our customers with security so that their products meet and fulfil the regulatory requirements, and assurance that they will not be at risk of making any mistakes that could cause additional costs,” says Dalia. “We can provide customers with packaged solutions tailored to their needs, both when it comes to regulations and an effective quality process. We can make sure that all the steps are followed, which leads to better traceability and quality assured product.”
Dalia points out that our clients get so much more than just one person when working with consultants from Key2Compliance, “The clients that I work with may be familiar with my face, but I have at least 70 other people with me – or, at least, their excellent expertise and experience. We at Key2Compliance have a high sense of team and we are very keen that knowledge and experience are shared with each other within the company through workshops, collaborations, and more, so we can help our clients in an even better way.”
“If I don’t have the answer the client needs, I know that I will find it within 30 minutes with the help of my competent colleagues. This is how we help our clients to be both compliant and successful.”