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EU MDR & IVDR Readiness: Mastering Economic Operator and PRRC Roles
This episode breaks down the critical responsibilities of Economic Operators—Manufacturer, Authorised Representative, Importer, and Distributor—and the Person Responsible for Regulatory Compliance (PRRC) under the EU's MDR and IVDR. We explore the common operational pitfalls, such as role confusion, misaligned contracts, and PRRC coverage gaps, that frequently lead to audit findings and can jeopardize your market access in the European Union.
Key Questions:
- What are the four legally distinct Economic Operators under the EU MDR?
- How do the responsibilities of an Importer differ from those of a Distributor?
- Who is required to appoint a Person Responsible for Regulatory Compliance (PRRC)?
- What are the primary duties of a PRRC in ensuring device compliance?
- How can poorly defined contracts between operators lead to audit failures?
- What are the risks of having a gap in your PRRC coverage?
- Why is the Authorised Representative essential for non-EU manufacturers?
Pure Global offers end-to-end regulatory consulting for MedTech and IVD companies, streamlining global market access. We specialize in defining clear regulatory strategies, including the proper setup of economic operator roles and PRRC responsibilities to ensure EU MDR and IVDR compliance. Our experts act as your local representative in over 30 markets, managing technical dossiers and post-market surveillance. By combining local expertise with advanced AI tools, we help you navigate complex regulations efficiently. Need to align your compliance framework? Contact Pure Global at [email protected], visit us at https://pureglobal.com, or explore our FREE AI tools and database at https://pureglobal.ai.
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By Pure GlobalThis episode breaks down the critical responsibilities of Economic Operators—Manufacturer, Authorised Representative, Importer, and Distributor—and the Person Responsible for Regulatory Compliance (PRRC) under the EU's MDR and IVDR. We explore the common operational pitfalls, such as role confusion, misaligned contracts, and PRRC coverage gaps, that frequently lead to audit findings and can jeopardize your market access in the European Union.
Key Questions:
- What are the four legally distinct Economic Operators under the EU MDR?
- How do the responsibilities of an Importer differ from those of a Distributor?
- Who is required to appoint a Person Responsible for Regulatory Compliance (PRRC)?
- What are the primary duties of a PRRC in ensuring device compliance?
- How can poorly defined contracts between operators lead to audit failures?
- What are the risks of having a gap in your PRRC coverage?
- Why is the Authorised Representative essential for non-EU manufacturers?
Pure Global offers end-to-end regulatory consulting for MedTech and IVD companies, streamlining global market access. We specialize in defining clear regulatory strategies, including the proper setup of economic operator roles and PRRC responsibilities to ensure EU MDR and IVDR compliance. Our experts act as your local representative in over 30 markets, managing technical dossiers and post-market surveillance. By combining local expertise with advanced AI tools, we help you navigate complex regulations efficiently. Need to align your compliance framework? Contact Pure Global at [email protected], visit us at https://pureglobal.com, or explore our FREE AI tools and database at https://pureglobal.ai.