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The new 2017/745/EU Medical Device Regulations (MDR-2020) require increased emphasis on Post- Market Clinical Follow-Up (PMCF) as a part of clinical evaluation to demonstrate conformity to safety and performance of devices. Many device manufacturers are unaccustomed to conducting post- marketing clinical studies and tend to regard study activity as both costly and time-intensive. Proper design, planning and execution of PMCF studies are essential to ensure return on investments.

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