This revision provides more detailed guidance on requirements for the frequency of evaluation report updates. Because the changes focus mainly on clarification of certain concepts, it is expected that manufacturers will follow the guidance immediately.įrequency Of Clinical Evaluation Report Updates This article summarizes the most significant differences between this and the previous guidance. The document also covers requirements specifically for postmarket surveillance and postmarket clinical follow-up. The MEDDEV guidance document 2.71 revised and released by the European Commission this year instructs manufacturers how to properly conduct a clinical evaluation, including demonstration of the scientific validity of data and conclusions.
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