MedTechLabel WP2 T1.1 Information Model Guide, published by HL7 Europe. This guide is not an authorized publication; it is the continuous build for version 0.4.3 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/hl7-eu/medtechlabel-wp2-im/ and changes regularly. See the Directory of published versions

Information Model

The following information model aligns all details from the mindmap resp. value set in form of an UML class diagram:

Not Considered (yet)

The following information objects are not included into the information model:

• organisations
  • importer
  • distributor
• person
  • subject (= patient)
  • user

Explanation

• A medical device (MD) is normally delivered in a package. It can exist on its own.
• A MD can be separately packed in different containers. For example, an injection needle can be delivered in a pack of 1000, each packed on a strip of 100 (=container).

In case of doubt how to read and understand this diagram please consult as short explanation.