The advent of the EU Medical Device Regulations (EU MDR) and In-Vitro Diagnostic Regulation (IVDR) signals a new era of intensified scrutiny and transparency in the medical device sector. The Person Responsible for Regulatory Compliance (PRRC), emerges as a crucial term within the framework of the new EU MDR and EU IVDR. These regulations underline the significance of having a knowledgeable regulatory expert, i.e., the PRRC, to ensure that companies adhere to the rigorous regulatory demands.
The PRRC is a designated figure or entity within a medical device manufacturer's organizational structure ensuring ongoing adherence to the stringent standards stipulated by the EU MDR and EU IVDR. Their presence ensures that devices introduced to the market conform to the highest safety and performance benchmarks, thereby safeguarding patients and boosting public trust.
Qualifications and Criteria for a PRRC
The qualifications required for a PRRC are explicitly outlined in Article 15 of both EU MDR and EU IVDR. The PRRC must
meet one of the subsequent criteria.
Possessing a formal degree, certificate, or equivalent recognition in areas like law, medicine, pharmacy, engineering, or other relevant sciences. Furthermore, a minimum of one year of professional experience in regulatory affairs or quality management systems pertaining to medical devices is expected. If qualifications are acquired outside the EU, they should be deemed equivalent by an EU Member State.
Alternatively, a PRRC can possess four years of professional experience in Regulatory Affairs or Quality Management Systems specific to medical devices and EU requirements.
PRRC across various MedTech companies
Notably, companies have the option to appoint more than one PRRC, allowing responsibilities to be shared, provided each appointed individual meets the requisite qualifications and the division of roles is well-documented.
PRRC for Micro and Small Enterprises
Micro and small businesses might face a unique challenge. The CEOs of such enterprises may wonder if they can spare resources for a PRRC. The EU commission acknowledges this concern by mandating a PRRC, albeit not within the organization itself. While larger manufacturers are mandated to have an in-house PRRC if they have at least 50 employees, small and micro manufacturers can opt to have a PRRC available at their disposal. Such businesses need a PRRC "Permanently" and "Continuously" available, which can be fulfilled by a consultant. The consultant's presence should be on standby to address the business's needs promptly. While this requirement might seem perplexing, it essentially demands accessibility during regular office hours to ensure compliance without excessive costs.
PRRC for European Authorized Representatives (EAR)
The European Authorized Representatives (EAR) representing non-EU manufacturers within the European Union need a PRRC to work alongside them, ensuring compliance with regulations. The PRRC requirements for Authorized Representatives mirror those for Micro and Small Enterprises. The PRRC can either be part of the organization or external, but the key lies in their perpetual and continuous availability.
Custom-Made Medical Device Manufacturing companies
For companies manufacturing custom-made devices, qualification criteria differ slightly. The PRRC candidate with a formal degree should possess two years of experience in the industry instead of one. If they possess four years of industry experience, they qualify without the need for a specific diploma. This recognition of the unique nature of custom-made devices acknowledges the specialized knowledge required for these products.
PRRC’s designated location
The location of a PRRC is significant, with a close connection to the manufacturer. If a manufacturer is based outside the EU, it is expected that their PRRC would also be located outside the EU. Similarly, micro and small manufacturers within the EU must have a PRRC within the EU's geographical boundaries. The PRRC should also be continuously available for European Authorized Representatives (EAR), who also must be situated within the EU.
Unveiling the Roles and Responsibilities of PRRC
The responsibilities and roles of a PRRC are multifaceted.
● Ensure Device Conformity with Medical Device Regulation and Quality Management System
● Overseeing Technical Documentation and EU Declaration of Conformity
● Remaining Abreast of Regulatory Updates and Ensuring Ongoing Compliance
● Collaborating with Competent Authorities on Post-Market Surveillance and Vigilance
● Acting as a Liaison with Regulatory Authorities in Device Registration and Compliance
● Assuming an Essential Role in Company Governance Pertaining to Regulatory Affairs
Comparison between PRRC and Management Representative (MR)
The Management Representative (MR), a requirement under ISO 13485, an international quality management standard for medical devices focuses on the efficacy of quality management systems but doesn't delve into regulatory aspects. The PRRC's role, however, covers regulatory compliance, clinical evaluations, and vigilance reporting, aligning directly with EU MDR and EU IVDR demands. While both roles differ, they can be harmonized within an organization. One individual can serve as both the PRRC (for regulatory compliance) and the MR (for quality management systems). This integration is particularly viable for small and medium-sized enterprises.
Embarking on Your PRRC Journey
To establish a PRRC within your organization:
● Identify a candidate who fulfils the qualification requirements
● Evaluate whether an internal employee can be upskilled into the role or if external recruitment is necessary.
● Provide or facilitate the necessary training, if required.
● Document and ensure the PRRC's roles and responsibilities are well-defined.
● Ensure the PRRC is seamlessly integrated into your regulatory and quality frameworks.
In the ever-evolving landscape of medical device regulations, the introduction of the EU MDR and IVDR has brought about a paradigm shift in how companies ensure compliance, quality, and patient safety. At the heart of these regulations is the role of the Person Responsible for Regulatory Compliance (PRRC). The PRRC plays a crucial role in guiding companies through the intricate maze of regulatory requirements, ensuring that medical devices meet the highest standards and adhere to ongoing compliance.
Are you prepared to navigate the complex terrain of EU MDR and IVDR compliance? Our team of regulatory experts is here to guide you through the intricacies of the PRRC role and help you achieve seamless compliance while upholding the highest standards of product quality and patient safety.
Contact us today to embark on a journey of regulatory excellence and innovation in the field of medical devices.