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Post-Market Clinical Follow-Up: Regulatory Obligations and Documentation Strategies
📢 DDReg Knowledge Capsule – Episode [27]
This podcast covers Post-Market Clinical Follow-up (PMCF) under the European Union’s Medical Device Regulation (MDR). It describes how manufacturers must transition from passive monitoring to a continuous, proactive process of gathering clinical data throughout a product’s entire lifecycle. The source outlines the necessity of creating defensible documentation, specifically highlighting the PMCF Plan and the Evaluation Report as key tools for maintaining compliance. Furthermore, it details various methodologies for data collection, such as clinical…
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