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When the device is manufactured by the original equipment manufacturer (OEM) and your company name (Own Brand Labeling – OBL, virtual manufacturer) is on the label – your Company will be considered a legal manufacturer.
The manufacturer is any natural or legal person responsible for designing or manufacturing a product and placing it on the market under his own name or trademark.
The definition contains two cumulative conditions: the person must manufacture (or have a product manufactured) and market the product under his own name or brand. So, if the product is marketed under your name, you will be considered a legal manufacturer (Blue Guide 2022/C 247/01) with all manufacturer obligations (MDR, Art.10).
BioReg advises on all label and legal issues related to virtual manufacturing.
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