Are you a Distributor or a Private Label Manufacturer under the EU MDR

The video provides a detailed comparison between the roles of distributors and private label manufacturers under the EU Medical Device Regulation (MDR). Distributors are responsible for the logistics and supply chain but do not alter or rebrand the devices, whereas private label manufacturers market devices produced by another company under their own brand name, assuming full regulatory responsibility as the legal manufacturer. The document highlights that distributors cannot apply for CE certification as it requires fulfilling extensive regulatory obligations, which is beyond their scope.
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[@prafullakumarpatil8916]

Nice video