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Reclassification<br>“Decide route regarding conformity evaluation”<br><br>Legacy product market access<br>“Ensuring products are CE marked”<br><br>Single Use Device Reprocessing<br>“Reprocessing allowed only under national law”<br><br>Technical Documentation<br>“Stringent technical documentation”<br><br>Clinical Evaluation<br>“Warrants entensive clincal evidence”<br><br>Post Market Surveillance and vigilance<br>“Assimilate post market clinical data”<br><br>Mandatory insurance for Product Liability<br>“Ensuring substantial coverage is provided for liability”<br><br>Transparency<br>“Closely monitor EUDAMED”<br><br>Labeling<br>“More prescriptive labeling requirement”<br><br>Unique Device Identification<br>“Mandatory tracing of all medical devices”<br>
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Reclassification “Decide route regarding conformity evaluation” Legacy product market access “Ensuring products are CE marked” Single Use Device Reprocessing “Reprocessing allowed only under national law” Technical Documentation “Stringent technical documentation” Clinical Evaluation “Warrants entensive clincal evidence” Post Market Surveillance and vigilance “Assimilate post market clinical data” Mandatory insurance for Product Liability “Ensuring substantial coverage is provided for liability” Transparency “Closely monitor EUDAMED” Labeling “More prescriptive labeling requirement” Unique Device Identification “Mandatory tracing of all medical devices” For Enquires or Quote please contact, info@medicalwritingexperts.com www.medicalwritingexperts.com
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