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3 min read
Entering the EU (European Union) under the new Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) can be complex and daunting for medical device companies. For companies outside the EU, understanding the roles and responsibilities of the Authorized Representative and Person Responsible for Regulatory Compliance is crucial for a successful market entry.
Understanding the IVDR and MDR
The IVDR and MDR are the EU's updated regulatory frameworks for medical devices and in vitro diagnostic devices. These regulations help enhance the safety, performance, and traceability of medical devices in the EU market. Unlike the previous Medical Device Directive (MDD), the MDR focuses on the responsibilities and liabilities of various economic operators, including manufacturers, ARs, importers, and distributors.
Key Roles: Authorized Representatives and Person Responsible for Regulatory Compliance
Authorized Representatives (AR)
An Authorized Representative (AR) is a legal entity established in the European Union that acts on behalf of a manufacturer located outside the EU.
The roles played by Authorized Representatives include:
- Verifying the EU declaration of conformity and technical documentation, ensuring they are drawn up correctly, and where applicable, that the conformity assessment procedure is used by the manufacturer.
- Cooperating with the competent authorities on any preventive or corrective actions necessary to eliminate or mitigate the risks posed by the medical devices.
- Maintaining a copy of the technical documentation, the EU declaration of conformity, and certificates, including amendments, at the competent authority for a specified period.
The Person Responsible for Regulatory Compliance (PRRC): Both the ARs and the manufacturer must appoint at least one PRRC. The PRRC's role is essential in managing the Quality Management System (QMS), regulatory documentation, post-market surveillance (PMS), vigilance reporting, and ensuring compliance of devices used in clinical investigations.
Key requirements include:
- The PRRC must have the requisite expertise in the field of medical devices or in vitro diagnostic devices, depending on the type of product.
- For manufacturers, the PRRC must be an employee unless the company qualifies as a small manufacturer of medical devices.
- ARs must have the PRRC permanently and continuously available, although the person is not required to be employed by the Authorized Representative.
Implication of the MDR for Authorized Representatives:
The MDR has increased the compliance responsibilities and legal liabilities of ARs. ARs are now jointly liable with manufacturers for defective devices if the manufacturer fails to comply with EU obligations.
This ensures that manufacturers cannot bypass their regulatory responsibilities by relying on ARs who fail to meet their obligations.
Key implications for ARs include:
- Mandatory registration in the European database (EUDAMED).
- Liability on the same basis as manufacturers, which enhances the importance of ARs in the compliance process.
Navigating the Transitions: Key Steps for Compliance
- Identify and appoint the right AR and PRRC: Carefully select your AR and PRRC based on their experience, qualifications, and understanding of MDR and IVDR compliance. Ensure that the roles and responsibilities are clearly defined and documented.
- Develop or update your Quality Management System (QMS): Ensure your QMS aligns with the requirements of the MDR and IVDR, including aspects such as PMS, vigilance reporting, and clinical evaluation.
- Preparation of comprehensive technical documentation: The technical documentation must be thorough, well-organized, and readily available for review by the AR and competent authorities. This includes the EU declaration of conformity, risk management files, clinical evaluation reports, and product labeling.
- Stay informed and engage with competent authorities: Regularly engage with your AR to stay updated on any regulatory changes or updates in the EU region. Actively communicating with the competent authorities helps address any compliance issues promptly.
- Invest in training and compliance resources: Investing in training for your regulatory team, including the PRRC, ensures that your organization remains up to date with the latest regulatory updates and requirements.
- Conduct a thorough risk assessment: Evaluate the potential risks associated with the medical devices and the compliance responsibilities of ARs. Implement robust measures to mitigate these risks and ensure that both production and regulatory processes adhere to EU MDR and IVDR standards.
Conclusion
Navigating the MDR and IVDR requirements is essential for medical device manufacturers entering the EU market. Understanding the roles of Authorized Representatives and the Person Responsible for Regulatory Compliance, and taking proactive steps to adhere to regulatory compliance, can help companies mitigate compliance risks and enhance their market access strategy.
As the EU regulatory landscape continues to evolve, staying updated with EU regulatory compliance is highly important. Our experts at Freyr specialize in EU market entry and regulatory affairs. To learn more, contact our experts today.
