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EU IVDR: Strengthening Your MedTech Supply Chain Controls
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…
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