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From GlobalCompliancePanel
Construct and Manage the Technical File and Design Dossier - Webinar By GlobalCompliancePanel
...s are retained on the premises of the manufacturer or the Authorized Representative for potential review of Competent Authorities and Notified Body. Dossiers have to be submitted to the Notified Body for review prior CE-Marking of your product. It is not necessary to include all documents in the design dossier which have already been subject to an ISO/ MDD type Audit by the Notified Body.
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