This episode delves into the critical supply chain requirements for Economic Operators under the EU's In Vitro Diagnostic Regulation (IVDR), referencing insights from April 14, 2025. We explore common pitfalls leading to Notified Body non-conformities, the specific obligations for manufacturers, importers, distributors, and authorized representatives, and strategies for ensuring your quality agreements and operational controls meet the stringent IVDR demands for enhanced traceability and patient safety in the EU market.

Key Questions:

• What are the four types of Economic Operators under EU IVDR and their core responsibilities?

• Why are robust supply chain controls crucial for IVDR compliance and avoiding non-conformities?

• Have the obligations for Economic Operators truly changed since May 2022, even for legacy devices?

• What are the most common mistakes manufacturers make when defining Economic Operator roles and agreements?

• How does EN ISO 13485 relate to controlling outsourced Economic Operator activities under IVDR?

• What impact do new labeling, registration, and EUDAMED requirements have on IVD supply chains?

• How can you ensure your quality agreements are up-to-date with IVDR Article 10-16 obligations?

• Why is an existing ISO 13485 certificate not a guaranteed pass for supply chain audits?

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