MedTechLabel WP2 T2.2 Information Model Guide, published by HL7 Europe. This guide is not an authorized publication; it is the continuous build for version 0.4.15 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
The (following) information model shall align all details from
the mindmap resp. value set
in form of an UML class diagram.
All identified objects and details artefacts (attributes) must be present somewhere:
This information model currently represents a draft for discussion!
Adjustments can be expected during the course of WP2.
Feedback is highly appreciated.
Not Considered (yet)
The following information objects are not included into the information model or requires a further improvement:
package
is a logical item that collects what belongs to a device
is also a container that physically contains different items
individual organisations in specific roles
importer
distributor
..
person
subject (= patient)
user
Explanation
The model ist devided into three parts that are presumably hard to understand:
Some object will exist physically, eg. that device itself, printed information, and separatable parts.
Some objects will only exist in a abstract or just electronic form.
Finally, some objects are somehow "abstract".
For example, the label is an abstract object that needs a definition.
But it can also exist in an electronic or printed form.
Or the package. It is a term when talking about what belongs to a medical device.
On the other hand it is the outer container that contains everything.
A medical device (MD) is normally delivered in a package. It can exist on its own.
Almost all items mentioned in the model can exist on its own. They can be separated, but are not automatically destroyed.
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.
Further Clarification needed
When analysing the requirements in the Excel sheet
the following ones need further examination and modelling:
P1-003: what shall the symbol represent?
P1-004: what is a UDI-carrier?
is "marking" and "markingInformation" the same?
P1-022: single-use devices can be reprocessed?
P1-034: analyse!!!
P1-058: CSIRTS
P1-058: ENISA
P1-084: analyse!!!
P1-090b: analyse!!!
P1-091: analyse!!!
P1-104: analyse!!!
P1-105: analyse!!!
P1-107: analyse!!!
P1-112: analyse!!!
P1-121: analyse!!!
P1-123: analyse!!!
P1-172: analyse!!!
P1-174: analyse!!!
P1-176: analyse!!!
P1-177: analyse!!!
P1-184: analyse!!!
P1-188: analyse!!!!! <- additional guidance for users!
P1-189: analyse!!!
P1-213: analyse!!!
P3-xxx: all items require further analysis, eventually separating into different information models
