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

CodeSystem: Device Class (Experimental)

Official URL: http://www.hl7europe.org/medtechlabel/CodeSystem/DeviceClass Version: 0.4.3
Active as of 2026-09-29 Computable Name: DeviceClassCS
Other Identifiers: OID:1.2.3.4.5.6.7.8.9.9

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.

This Code system is referenced in the content logical definition of the following value sets:

  • This CodeSystem is not used here; it may be used elsewhere (e.g. specifications and/or implementations that use this content)

This case-sensitive code system http://www.hl7europe.org/medtechlabel/CodeSystem/DeviceClass defines the following codes in a Is-A hierarchy:

LvlCodeDisplayDefinitionDeutsch (German, de)
1 I class I class I (low risk) Klasse I
1 II class II class II (moderate risk) Klasse II
2   IIa class IIa class IIa (low to moderate risk) Klasse II
2   IIb class IIb class IIb (moderate to high risk) Klasse II
1 III class III class III (high risk) Klasse III