What is the OBL contract?

The term Own Brand Labeling (OBL) refers to the particular procedure that a medical devices manufacturer should follow when marketing devices bearing a CE marking in its own name (“me too” device). The European Regulation considers the OBL manufacturer as the legal manufacturer even when he is not involved in the device manufacturing. Consequently, the relationship between the company that manufactures the device and includes the CE marking, known as Original Equipment Manufacturer (OEM), and the company that intends to market it in OBL, must be regulated by a contract. In this contract the involved parts roles must be defined, as well as the manners of communication and access to sensitive information of the device subject to the contract.