EU MDR & IVDR Readiness: Mastering Economic Operator and PRRC Roles

Medical Device Global Market Access · Feb 11, 2026 · 3m

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…