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Lauren Kim

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United States

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Posted By Lauren Kim 02-Aug-2020 14:53
Found In Egroup: Regulatory Open Forum
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Can anyone inform what type of documents should be submitted to the legacy MDD class III devices (already in the market) to be converted to MDR? Some say only postmarket date such as adverse drug reactions are required, but is this applied to class III devices, or do we need to submit clinical trial ...