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Europe In Brief

This article was originally published in The Gray Sheet

Executive Summary

European clinical evaluation guidelines: The European Commission in December issued revised 1clinical evaluation guidelines explaining how manufacturers should conduct and document clinical evaluations of devices both before and after putting them on the market. "The clinical evaluation is expected to address the significance of any risks that remain after design risk mitigation strategies have been employed by the manufacturer," the guidelines state. The document notes that the extent of clinical evaluation needed depends on the nature, classification, intended use and risks of the particular device. For many devices embodying incremental modifications, it will be possible to draw on clinical experience with and literature reports on the safety and performance of equivalent devices, the guidelines note. For other devices - such as high risk devices, devices based on technologies where there is little or no experience, or those that represent a new clinical use - clinical investigations are likely to be required. The new guidelines, entitled MEDDEV 2.7.1 Rev. 3, take effect March 21 (2"The Gray Sheet" Aug. 17, 2009). They apply to medical devices generally and the device component of combination products; they do not cover in vitro diagnostics

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