Eudamed and UDI, a Curse in Disguise

Eudamed, the European Database for Medical devices, brings together data on manufacturers, authorized representatives and importers and the devices they are involved with. UDI is used to identify devices unambiguously at the level of device type as well as production (batch number, serial number etc.) Economic operators are required to supply this information and keep it updated. The authorities and the notified bodies will use this information for their surveillance activities. 

The concepts of Eudamed and UDI means extra information on the label, but also extra data management in the whole distribution chain. This looks like a lot of extra work for companies, only to enable the authorities getting a better grip on compliance. That is only part of the story. A manufacturer may get a better understanding of the distribution of his devices and a smart use of UDI may even enable generating high quality PMS data. UDI may be used for developing stronger scientifically sound clinical evidence and it can also be used for protection against counterfeit. Eudamed and UDI can therefore help protecting against fraud, increase product safety and assist in a higher added value to the device. Economic operators, and especially manufacturers, should embrace this concept.