The state of the Art Evaluation is a necessary component of Clinical Literature Evaluations (CERs) based on the European Union (EU) Medical Device Regulation (MDR), In Vitro Diagnostic Regulation (IVDR), and current regulatory guidance.
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There is the expectation under current European Union (EU) regulations that the state of the art evaluation, part of Clinical Literature Evaluations (CLEs), contains similar device data, among other information. Similar devices are devices that have the same or similar intended purpose as the device(s) under assessment. Information in the state of the art evaluation regarding similar devices must also be consist with manufacturers’ internal documentation.
This article defines similar devices and best practices for similar device data included in state of the art evaluations and CERs under EU regulations. Read the article here.
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