Private Label Manufacturer (PLM)

A Private Label Manufacturer (PLM) purchases a finished (or component parts of a) medical device from the Original Equipment Manufacturer (OEM), which he then places on the market under his own name or trade mark (brand label).

This PLM may not be the person who actually designs, manufactures, packages or labels the device. The PLM meets the definition of manufacturer as set out in the Medical Device Directive and is therefore considered as the legal Manufacturer