Own brand labelling (OBL), or private labelling, is used to describe the situation in which a person or organisation places devices on the market under their own name or trademark, and where those devices have already been subject to appropriate conformity assessment under the directive for the same intended use by another organisation. That is, the original device already bears the CE marking. The organisation now placing the device on the market under their own name may be referred to as an ‘own brand labeller’ or ‘private label manufacturer’ and henceforth will need to fulfil the obligations of a ‘manufacturer’ as defined in the Directive.
The original holder of the CE certificate is known as either the “Original Equipment Manufacturer” (OEM) or “Original Equipment Supplier” (OES). The OBL-issued CE certificate piggybacks on the existing CE marking certificate held by the OEM; however, the OEM is not disclosed on the OBL manufacturer’s certificate. The CE marking placed on the devices will be associated with the identification number of the notified body (NB) chosen by the own brand labeller. The organisation placing the device on the market in their own name must comply with all of the relevant requirements of the Directive. The CE marking that will be placed on the devices will be associated with the identification number of the notified body chosen by the own brand labeller.
LRQA will perform an assessment of the quality management system of the organisation placing the devices on the market against the provisions of the chosen conformity route.