MDD - Own Brand Labelling

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 "links" to 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 is associated with the identification number of the notified body (NB) chosen by the own brand labeller. Organisations placing devices 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.

When does Own Brand Labelling not apply?

  • Organisations which change (other than the representation of the "manufacturer" placing the devices on the market) the device, including its intended use, compared to the device as originally conformity assessed and CE marked
  • Devices sourced from suppliers and to be placed on the market in the name of a 'new' manufacturer, those devices not having previously been subjected to appropriate conformity assessment under the Directive
  • Organisations which fulfill the definition of a "manufacturer" for placing devices on the market, but which do not themselves perform all the required activities and have, therefore, "subcontracted" any of those activities to other parties. Examples of such activities are design and/or production
  • Distributors which sell on other manufacturer’s devices but do not themselves take the responsibility of "manufacturers" by relabeling the devices.

Download the LRQA Thought Leadership Article

The medical regulatory landscape is undergoing its most significant overhaul in years. Learn about the regulatory expectations for CE marking certification of medical devices and how the changes impact your organisation as well as discover the applications of OBL in the LRQA Thought Leadership article on CE Marking. Download your PDF copy using the link below:

LRQA Thought Leadership
Own Brand Labelling of Medical Devices: Clarifying Current Expectations for CE Certification
LRQA Food Fraud White Paper