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EU Market Access Secrets: Selecting the Best Medical Device Authorized Representative with Pure Global's Expert Insights
In this episode of MedTech Global Insights, we explore one of the most critical decisions for non-EU device manufacturers: selecting an EU Authorized Representative (EUAR). Under the stringent MDR and IVDR, this role has evolved from a simple address to a legally liable partner responsible for your compliance. We uncover the significant risks of choosing the wrong representative, from passive 'mailbox' services to conflicted commercial distributors.
This discussion serves as a strategic guide for MedTech and IVD companies, offering a clear framework for what defines a best-in-class EUAR. We break down the essential qualities to look for, including deep regulatory expertise, robust quality systems, and true independence, ensuring your partner is positioned to protect your market access and reputation in the complex European landscape.
A real-world example of the risk: A U.S.-based scaleup appointed its EU distributor as its Authorized Representative to save costs. When a post-market surveillance report revealed a potentially serious software bug, the distributor delayed reporting it to the Competent Authorities for over a month, fearing it would jeopardize a major hospital tender. The delay was discovered during a random audit, resulting in a mandatory market recall, significant fines, and a complete breakdown of the commercial relationship.
Key takeaways from this episode:
1. Why is your EU Authorized Representative now considered jointly liable for defective devices under the MDR?
2. What are the key differences between a passive 'mailbox' service and a proactive regulatory partner?
3. How can appointing your distributor as your representative create a critical conflict of interest in vigilance reporting?
4. What specific questions must you ask a potential EUAR about their Quality Management System and liability insurance?
5. How does a qualified EUAR assist during unannounced inspections by Competent Authorities?
6. What is the EUAR’s official role in verifying your technical documentation and Declaration of Conformity?
7. How can an independent representative help you navigate complex post-market surveillance and incident reporting?
8. Why is proactive regulatory intelligence from your EUAR a significant competitive advantage?
To learn more or discuss your regulatory strategy, contact us at [email protected] or visit https://pureglobal.com/
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By Ran ChenIn this episode of MedTech Global Insights, we explore one of the most critical decisions for non-EU device manufacturers: selecting an EU Authorized Representative (EUAR). Under the stringent MDR and IVDR, this role has evolved from a simple address to a legally liable partner responsible for your compliance. We uncover the significant risks of choosing the wrong representative, from passive 'mailbox' services to conflicted commercial distributors.
This discussion serves as a strategic guide for MedTech and IVD companies, offering a clear framework for what defines a best-in-class EUAR. We break down the essential qualities to look for, including deep regulatory expertise, robust quality systems, and true independence, ensuring your partner is positioned to protect your market access and reputation in the complex European landscape.
A real-world example of the risk: A U.S.-based scaleup appointed its EU distributor as its Authorized Representative to save costs. When a post-market surveillance report revealed a potentially serious software bug, the distributor delayed reporting it to the Competent Authorities for over a month, fearing it would jeopardize a major hospital tender. The delay was discovered during a random audit, resulting in a mandatory market recall, significant fines, and a complete breakdown of the commercial relationship.
Key takeaways from this episode:
1. Why is your EU Authorized Representative now considered jointly liable for defective devices under the MDR?
2. What are the key differences between a passive 'mailbox' service and a proactive regulatory partner?
3. How can appointing your distributor as your representative create a critical conflict of interest in vigilance reporting?
4. What specific questions must you ask a potential EUAR about their Quality Management System and liability insurance?
5. How does a qualified EUAR assist during unannounced inspections by Competent Authorities?
6. What is the EUAR’s official role in verifying your technical documentation and Declaration of Conformity?
7. How can an independent representative help you navigate complex post-market surveillance and incident reporting?
8. Why is proactive regulatory intelligence from your EUAR a significant competitive advantage?
To learn more or discuss your regulatory strategy, contact us at [email protected] or visit https://pureglobal.com/