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EU MDR Clinical Investigations: Navigating Deadlines and Data Requirements for European Market Access
This episode provides a detailed overview of the clinical investigation requirements under the European Union's Medical Device Regulation (MDR). We explore the critical distinctions between pre-market clinical investigations and post-market clinical follow-up (PMCF), the role of the Clinical Evaluation Report (CER) as a living document, and the key transitional deadlines that manufacturers of legacy devices must meet to maintain market access. We also touch on the function of the EUDAMED database in enhancing transparency. - What are the primary differences between clinical data requirements…
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