
Åsa Möllby
Director, Medical Device Quality Assurance – GBA Key2Compliance
One of the changes introduced by the Medical Device Regulation (MDR) in 2017 and the In Vitro Diagnostic Device Regulation (IVDR), is the requirement of a designated Person Responsible for Regulatory Compliance (PRRC). A PRRC bears the important role mandated by the MDR and IVDR of maintaining the safety, integrity, quality, and effectiveness of medical devices.
Simply put, the PRRC is tasked with ensuring that the regulatory requirements brought about by the MDR/IVDR, are consistently met.
A look at the responsibilities of a PRRC
Under the MDR and the IVDR, there are five major responsibilities outlined:
- The PRRC must verify the conformity of devices according to the company’s quality management system (QMS) before the devices are released.
- The PRRC will ensure that technical documentation and the EU declaration of conformity are available, maintained, and kept up to date.
- The PRRC will ensure that the company complies with post-market surveillance obligations as specified in Article 10(10) of the MDR or Article 10(9) of the IVDR.
- Moreover, the PRRC will be responsible for ensuring that the company fulfills its reporting obligations as outlined in Articles 87-91 of the MDR or Articles 82-86 of the IVDR.
- Lastly, the PRRC will ensure that the statement required by Section 4.1 of Chapter II of Annex XV of the MDR is issued if the company is developing an investigational device. For the IVDR, this statement is located in Section 4.1 of Annex XIV.
In addition to these responsibilities, due to the nature of their role, the PRRC must stay informed about regulatory changes and ensure that the company’s compliance practices are adapted accordingly. Additionally, the PRRC may also be responsible for promoting regulatory compliance within the organization by educating and training relevant staff on regulatory requirements and compliance practices, ensuring that the entire organization understands and adheres to these standards.
The authority of the PRRC
Both MDR and IVDR describe the responsibility of the PRRC but the authority is not described anywhere. As well as describing the responsibility of the PRRC in the company QMS it is also important to describe the authority. At Key2Compliance we would suggest to consider the following authorities of the PRRC:
- Decision-Making Authority
Stop Production Authority: The PRRC has the power to halt production or service delivery if quality issues are identified that could affect the final product or service’s compliance with standards.
Approval Authority: PRRC has the authority to approve or reject products, materials, and processes based on quality criteria before they move to the next stage of production or reach the customer. - Policy and Procedure Enforcement
Authority to Enforce Standards: The PRRC can enforce compliance with established quality policies, standards, and procedures across the organization.
Audit and Inspection Authority: PRRC has the power to conduct or initiate audits, inspections, and reviews to ensure adherence to quality standards, and to demand corrective actions where necessary. - Authority Over Quality Control
Authority to Define and Implement Quality Control Measures: The PRRC has the authority to develop and enforce quality control processes, including the selection and use of specific tools, techniques, and practices.
Authorization to Use Quality Data: PRRC can utilize and interpret quality data to make decisions that affect production, processes, and product release. - Reporting and Compliance Authority
Authority to Report to Senior Management: The PRRC has direct access to senior management to report on quality issues, performance, and improvements.
Compliance Enforcement Authority: PRRC has the power to ensure that the company meets all relevant quality regulations and standards, including initiating actions to rectify non-compliance.
In summary, the authority of a PRRC is the formal power granted to them to make critical decisions related to quality, enforce compliance with standards, and interact with senior management to ensure that quality objectives are met.
Who can medical device companies designate as their PRRC?
Medical device companies must also keep in mind that under the MDR/IVDR, the following are the required qualifications of the individual designated as the PRRC:
- a diploma, certificate, or other formal qualifications awarded upon completion of a university degree or an equivalent course of study in law, medicine, pharmacy, engineering, or another relevant scientific discipline.
- at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices,
or at least four years of professional experience in these fields if there is no diploma, certificate, or other formal qualifications awarded.
While medical device companies are required to have a PRRC from within their organization, those with fewer than 50 employees and an annual turnover of less than EUR 10 million (classified as micro and small enterprises according to Commission Recommendation 2003/361/EC) are permitted to outsource their PRRC to an external expert. This is allowed under the conditions that the PRRC meets the qualification criteria and is permanently and continuously available to the company.
It is also worth noting that companies can opt to have more than one PRRC, in case they find it necessary.
Common challenges faced by medical device companies in relation to PRRCs
For companies who are qualified to outsource their PRRC, one of the bigger challenges is finding individuals who meet the stringent qualifications and experience requirements outlined by the MDR/IVDR. As previously tackled in this article, the regulations require specific educational backgrounds and professional experience in regulatory affairs or quality management systems related to medical devices.
Another challenge is ensuring that the designated PRRC is readily available to the company, which can be difficult for medical device companies who choose to outsource the role. This can potentially lead to delays in addressing compliance issues, ultimately affecting the organization’s capability to meet regulatory requirements and deadlines. Furthermore, compliance activities spearheaded by the PRRC require significant time, effort, and financial resources. Smaller companies, in particular, may find it difficult to allocate enough resources, potentially leading to shortcuts or oversights in regulatory practices.
Ensuring that all relevant staff is adequately trained and aware of regulatory requirements is crucial for maintaining compliance, but many companies tend to neglect ongoing training and awareness programs, as these usually cost time and money. This, however, can eventually lead to gaps in knowledge and understanding of regulatory requirements, ultimately leading to unnecessary hurdles.
Why having an industry expert as their PRRC matters for medical device companies
Aside from the fact that both the MDR and the IVDR require having a designated PRRC, medical device companies also stand to gain from the expertise of their PRRC, especially small and medium-sized enterprises that will opt to outsource the designated role – a qualified PRRC has a deep understanding of the regulatory environment, including the specific requirements of the MDR/IVDR. This expertise ensures that the company’s products meet all necessary standards before entering the market, thereby reducing the risk of non-compliance and potential recalls.
For smaller companies that may lack in-house regulatory expertise, outsourcing the PRRC role to a specialized consultant can provide access to this critical knowledge without the need to hire full-time staff. Again, due to the nature of their role, PRRCs are also usually committed to continuous improvement, instilling the same culture in the company and ensuring that the company remains compliant with current regulations and is prepared for future changes.
Another benefit of having an industry expert as the PRRC is that it can enhance the credibility of the medical device company. It shows continued commitment to quality and regulatory compliance, which can be a significant competitive advantage. Customers, partners, and regulators are more likely to trust a company that prioritizes compliance and has the expertise to back it up.
Due to these factors as well as the challenges previously outlined, it is crucial for medical device companies, especially small and medium-sized enterprises, to designate a PRRC that fits the culture of the company while still having the necessary experience to ensure rigorous regulatory compliance and effective communication with regulatory authorities.
Meet regulatory compliance today with an industry expert from GBA Key2Compliance !
With how important the role of a PRRC is, it is crucial for medical device companies to only employ the services of qualified professionals and industry experts from trusted consultancy firms. GBA Key2Compliance is a full-service partner with a team of consultants and industry professionals with extensive experience in regulatory compliance. We can help in designating a PRRC from our roster of experts and tailor our services depending on your specific needs.
Partner with us today and let us help you!