Terms, Definitions and Application

We use two terms in the context of our data model: Knowledge Topic (KT) and Knowledge Unit (KU). The KT represents the template: a description what is required from a regulatory point of view. The KU is created on the basis of the KT for a particular medical device and contains specific information related to the device.

Terms and Definitions


MDKU Medical Device Knowledge Units e.V. 

Am Weichselgarten 7

91058 Erlangen