MedTechLabel WP2 T1.1 Information Model Guide
0.4.3 - ci-build
MedTechLabel WP2 T1.1 Information Model Guide
0.4.3 - ci-build
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
| Active as of 2026-09-29 |
<CodeSystem xmlns="http://hl7.org/fhir">
<id value="DeviceClass"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p class="res-header-id"><b>Generated Narrative: CodeSystem DeviceClass</b></p><a name="DeviceClass"> </a><a name="hcDeviceClass"> </a><p>This case-sensitive code system <code>http://www.hl7europe.org/medtechlabel/CodeSystem/DeviceClass</code> defines the following codes in a Is-A hierarchy:</p><table class="codes"><tr><td><b>Lvl</b></td><td style="white-space:nowrap"><b>Code</b></td><td><b>Display</b></td><td><b>Definition</b></td><td><b>Deutsch (German, de)</b></td></tr><tr><td>1</td><td style="white-space:nowrap">I<a name="DeviceClass-I"> </a></td><td>class I</td><td>class I (low risk)</td><td>Klasse I</td></tr><tr><td>1</td><td style="white-space:nowrap">II<a name="DeviceClass-II"> </a></td><td>class II</td><td>class II (moderate risk)</td><td>Klasse II</td></tr><tr><td>2</td><td style="white-space:nowrap"> IIa<a name="DeviceClass-IIa"> </a></td><td>class IIa</td><td>class IIa (low to moderate risk)</td><td>Klasse II</td></tr><tr><td>2</td><td style="white-space:nowrap"> IIb<a name="DeviceClass-IIb"> </a></td><td>class IIb</td><td>class IIb (moderate to high risk)</td><td>Klasse II</td></tr><tr><td>1</td><td style="white-space:nowrap">III<a name="DeviceClass-III"> </a></td><td>class III</td><td>class III (high risk)</td><td>Klasse III</td></tr></table></div>
</text>
<url value="http://www.hl7europe.org/medtechlabel/CodeSystem/DeviceClass"/>
<identifier>
<system value="urn:ietf:rfc:3986"/>
<value value="urn:oid:1.2.3.4.5.6.7.8.9.9"/>
</identifier>
<version value="0.4.3"/>
<name value="DeviceClassCS"/>
<title value="Device Class"/>
<status value="active"/>
<experimental value="true"/>
<date value="2026-09-29T20:54:24+00:00"/>
<publisher value="HL7 Europe"/>
<contact>
<name value="HL7 Europe"/>
<telecom>
<system value="url"/>
<value value="http://www.hl7europe.org"/>
</telecom>
</contact>
<description
value="Medical devices are categorized based on their risk level,
invasiveness, and duration of contact with the body.
Regulatory bodies, such as the FDA in the US and authorities under the EU MDR."/>
<caseSensitive value="true"/>
<hierarchyMeaning value="is-a"/>
<compositional value="false"/>
<content value="complete"/>
<count value="5"/>
<concept>
<code value="I"/>
<display value="class I"/>
<definition value="class I (low risk)"/>
<designation>
<language value="de"/>
<value value="Klasse I"/>
</designation>
</concept>
<concept>
<code value="II"/>
<display value="class II"/>
<definition value="class II (moderate risk)"/>
<designation>
<language value="de"/>
<value value="Klasse II"/>
</designation>
<concept>
<code value="IIa"/>
<display value="class IIa"/>
<definition value="class IIa (low to moderate risk)"/>
<designation>
<language value="de"/>
<value value="Klasse II"/>
</designation>
</concept>
<concept>
<code value="IIb"/>
<display value="class IIb"/>
<definition value="class IIb (moderate to high risk)"/>
<designation>
<language value="de"/>
<value value="Klasse II"/>
</designation>
</concept>
</concept>
<concept>
<code value="III"/>
<display value="class III"/>
<definition value="class III (high risk)"/>
<designation>
<language value="de"/>
<value value="Klasse III"/>
</designation>
</concept>
</CodeSystem>