CE Manrk And Clinical Affairs
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I want ask about all clinical affairs of technical file related to CE Marking of class IIb paroducts
For general guidance on the requirements for the clinical evaluation requirements please refer to MEDDEV. 2.7.1 Rev.3 CLINICAL EVALUATION:A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES.
If you could be more specific with your query the medical device committee may be able to provide more detailed guidance.