PMCF Surveys for Class II a devices : basic requisites

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tinax

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Hi all, Question on PMCF Surveys for Class IIa devices. What are the basic requirements for such surveys? Is an IRB approved protocol needed? Is the patient consent needed? These surveys are for post market device. In that case, can a survey shared by the manufacturing company to the doctor who used the device, collecting the details of how the device performed from the doctor still need the above two?
 
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