Description Notified Body audits under the EU MDR /IVDR present new challenges for manufacturers, from increased scrutiny of technical documentation to evolving expectations around quality management systems and economic operator responsibilities. We'll provide practical insights on how to effectively prepare for and manage MDR / IVDR audits, understand what Notified Bodies are really looking for, and avoid common compliance pitfalls. It will also address frequently misunderstood MDR topics, including importer obligations, significant changes, and manufacturers' responsibilities.
Learning Objectives:
Understand key Notified Body expectations during MDR / IVDR audits
Prepare effectively for audits and manage them with confidence
Identify common compliance gaps and how to address them
Clarify common misconceptions around MDR / IVDR requirements and responsibilities
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