Elements of the Data Model:
from Documents to Knowledge
We identify single information units (“Knowledge Units”) contained in single documents of the technical documentation. Our goal is the provision of a data model that consists of all Knowledge Units required for compliance with requirements of MDR, Annex II and III.
Extraction of single information units in documents:
![](https://mdku.digital/wp-content/uploads/2023/09/MDKU_docs-knowledge_1-1024x683.png)
List of required information units for compliance with MDR, Annex II and III:
![](https://mdku.digital/wp-content/uploads/2023/09/MDKU_docs-knowledge_2-1024x665.png)
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.
![](https://mdku.digital/wp-content/uploads/2023/09/MDKU_definition_b-1024x361.png)
Terms and Definitions
![](https://mdku.digital/wp-content/uploads/2023/09/MDKU_application-1-1024x484.png)
Application
Hierarchy in the Data Model
In addition to definitions for single data model elements, we provide information about the hierarchy of individual knowledge topics, from a general, higher level down to very specific elements of the data model at lower levels.
![](https://mdku.digital/wp-content/uploads/2023/09/MDKU_hierarchy-1024x623.png)
Example for KT Hierarchy
Content of a Knowledge Topic
For each Knowledge Topic, we provide a clear description, attributes and additional information on the application of the Knowledge Topic, as well as background information explaining the regulatory basis of the chosen description.
![](https://mdku.digital/wp-content/uploads/2023/09/MDKU_content-of-knowledge_1-1024x380.png)
![](https://mdku.digital/wp-content/uploads/2023/09/MDKU_content-of-knowledge_2-1024x424.png)
![](https://mdku.digital/wp-content/uploads/2023/09/MDKU_content-of-knowledge_3-1024x454.png)
MDKU Medical Device Knowledge Units e.V.
Am Weichselgarten 7
91058 Erlangen
Germany