Own brand labelling

The Agency's position on Own Brand Labelling remains as detailed in Bulletin 19 - Own brand labelling and rented products (51Kb). In essence we remain of the opinion that the person placing a device on the market under his own name is the "manufacturer" as defined in the Regulations and carries the legal responsibility for that device.

We are aware, however, of situations involving Own Labellers (OBL) where this interpretation has caused difficulties. This arises where an OBL places a device on the market under his own name or trademark. As such the OBL becomes the manufacturer as defined, notwithstanding the fact that the device carries both his and the device maker's name and address. A possible way of overcoming this issue is for the OBL to licence back the right to use their trademark, in respect of the device in question, to the original maker of the device. In this way depending upon the precise terms of the licensing agreement, the maker of the device could become the 'manufacturer' as defined in the Regulations.

However, manufacturers and own brand labellers should take their own legal and professional advice, as each individual case will be different. The Agency is not able to advise on the terms of any licensing or contractual agreements.