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

Mindmap

The following mindmap should just accumulate all elements that appear in requirements (please see value set ) and sort it a little bit.

The (information model)[informationmodel.html] will be derived out of it.

Definitions / Glossary

For an explanation of terms please see the (glossary)[glossary.html].

Comments

medical device labelling for user story on pages 16-18: https://www.bsigroup.com/siteassets/pdf/en/insights-and-media/insights/brochures/bsi-md-mdr-best-practice-documentation-submissions-en-gb.pdf

Labeling

This section focuses on the relationship of an element with where it has to appear.

Element	on package (label)	on container	on device	on website
product (brand) name	x	x	?	x
description	x	?	-	x
class	x	-	?	x
type	x	-	-	x
amount of devices	x	-	-	-
serial number	x	-	x	-
expiry date	x	?	?	-
icon	x	-	?	-
IFU
eIFU
..

Device Types vs. Property

The following information elements are somehow overlapping between types and properties, ie. what expresses a device type and what can be treated as a property of the device:

Item	type	property
single use/reusable	?	x
implantable	?	x
sharp	-	x
disposable	-	x
sterilizable	-	x
nano technology	-	x

Icons

What are the necessary icons, e.g. from Safey Signs ISO 7010?

• sharp
• handle with care
• fragile
• …