BfArM Digitale Anwendungen
3.0.2-RC1 - draft

​BfArM Digitale Anwendungen - Local Development build (v3.0.2-RC1) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions

Extension: MedicalDevice on HealthAppModule

Official URL: https://fhir.bfarm.de/StructureDefinition/HealthAppModuleMedicalDevice Version: 3.0.2-RC1
Active as of 2026-02-25 Computable Name: Extension-HealthAppModuleMedicalDevice

Context of Use

    This extension may be used on the following element(s)

Usage info

Usages:

You can also check for usages in the FHIR IG Statistics

Formal Views of Extension Content

Description of Profiles, Differentials, Snapshots, and how the XML and JSON presentations work.

This structure is derived from Extension

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Extension S 0..1 Extension Medizinprodukt
... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:intendedPurpose S 0..1 Extension Zweckbestimmung
..... url 1..1 uri "intendedPurpose"
..... value[x] S 1..1 string Value of extension
.... extension:isMedicalDevice S 0..1 Extension Medizinprodukt
..... url 1..1 uri "isMedicalDevice"
..... value[x] S 0..1 boolean Value of extension
.... extension:notifiedBody S 0..1 Extension Benannte Stelle
..... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
...... extension:code S 0..1 Extension Kennnummer
....... url 1..1 uri "code"
....... value[x] S 1..1 string Value of extension
...... extension:name S 0..1 Extension Name
....... url 1..1 uri "name"
....... value[x] S 1..1 string Value of extension
..... url 1..1 uri "notifiedBody"
..... value[x] 0..0 Value of extension
.... extension:nursingBenefit S 0..1 Extension Pflegerischer Nutzen
..... url 1..1 uri "nursingBenefit"
..... value[x] S 1..1 string Value of extension
.... extension:regulatoryBasis S 0..1 Extension Regulatorische Grundlage
..... url 1..1 uri "regulatoryBasis"
..... value[x] S 1..1 code Value of extension
Binding: ValueSet for HealthAppRegulatoryBasis (required)
.... extension:riskClass S 0..1 Extension Risikoklasse
..... url 1..1 uri "riskClass"
..... value[x] S 1..1 code Value of extension
Binding: ValueSet for HealthAppRiskClass (required)
... url 1..1 uri "https://fhir.bfarm.de/StructureDefinition/HealthAppModuleMedicalDevice"
... value[x] 0..0 Value of extension

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Extension S 0..1 Extension Medizinprodukt
... id 0..1 string Unique id for inter-element referencing
... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:intendedPurpose S 0..1 Extension Zweckbestimmung
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... url 1..1 uri "intendedPurpose"
..... value[x] S 1..1 string Value of extension
.... extension:isMedicalDevice S 0..1 Extension Medizinprodukt
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... url 1..1 uri "isMedicalDevice"
..... value[x] S 0..1 boolean Value of extension
.... extension:notifiedBody S 0..1 Extension Benannte Stelle
..... id 0..1 string Unique id for inter-element referencing
..... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
...... extension:code S 0..1 Extension Kennnummer
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
....... url 1..1 uri "code"
....... value[x] S 1..1 string Value of extension
...... extension:name S 0..1 Extension Name
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
....... url 1..1 uri "name"
....... value[x] S 1..1 string Value of extension
..... url 1..1 uri "notifiedBody"
.... extension:nursingBenefit S 0..1 Extension Pflegerischer Nutzen
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... url 1..1 uri "nursingBenefit"
..... value[x] S 1..1 string Value of extension
.... extension:regulatoryBasis S 0..1 Extension Regulatorische Grundlage
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... url 1..1 uri "regulatoryBasis"
..... value[x] S 1..1 code Value of extension
Binding: ValueSet for HealthAppRegulatoryBasis (required)
.... extension:riskClass S 0..1 Extension Risikoklasse
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... url 1..1 uri "riskClass"
..... value[x] S 1..1 code Value of extension
Binding: ValueSet for HealthAppRiskClass (required)
... url 1..1 uri "https://fhir.bfarm.de/StructureDefinition/HealthAppModuleMedicalDevice"

doco Documentation for this format

This structure is derived from Extension

Summary

Complex Extension:

  • intendedPurpose: string: Die (medizinische) Zweckbestimmung entsprechend den Angaben des Herstellers auf der Kennzeichnung, in der Gebrauchsanweisung oder dem Werbe- oder Verkaufsmaterial bzw. den Werbe- oder Verkaufsangaben.
  • isMedicalDevice: boolean: Gibt an ob es sich beim Modul der digitalen Anwendung um ein Medizinprodukt handelt.
  • code: string: Kennnummer der benannten Stelle.
  • name: string: Name der benannten Stelle.
  • nursingBenefit: string: Nur DiPA: Die Beschreibung des pflegerischen Nutzens nach § 9 DiPAV.
  • regulatoryBasis: code:
    • mdd: Medical Device Directive
    • mdr: Medical Device Regulation
  • riskClass: code: Die Angabe der Risikoklasse.

Differential View

This structure is derived from Extension

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Extension S 0..1 Extension Medizinprodukt
... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:intendedPurpose S 0..1 Extension Zweckbestimmung
..... url 1..1 uri "intendedPurpose"
..... value[x] S 1..1 string Value of extension
.... extension:isMedicalDevice S 0..1 Extension Medizinprodukt
..... url 1..1 uri "isMedicalDevice"
..... value[x] S 0..1 boolean Value of extension
.... extension:notifiedBody S 0..1 Extension Benannte Stelle
..... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
...... extension:code S 0..1 Extension Kennnummer
....... url 1..1 uri "code"
....... value[x] S 1..1 string Value of extension
...... extension:name S 0..1 Extension Name
....... url 1..1 uri "name"
....... value[x] S 1..1 string Value of extension
..... url 1..1 uri "notifiedBody"
..... value[x] 0..0 Value of extension
.... extension:nursingBenefit S 0..1 Extension Pflegerischer Nutzen
..... url 1..1 uri "nursingBenefit"
..... value[x] S 1..1 string Value of extension
.... extension:regulatoryBasis S 0..1 Extension Regulatorische Grundlage
..... url 1..1 uri "regulatoryBasis"
..... value[x] S 1..1 code Value of extension
Binding: ValueSet for HealthAppRegulatoryBasis (required)
.... extension:riskClass S 0..1 Extension Risikoklasse
..... url 1..1 uri "riskClass"
..... value[x] S 1..1 code Value of extension
Binding: ValueSet for HealthAppRiskClass (required)
... url 1..1 uri "https://fhir.bfarm.de/StructureDefinition/HealthAppModuleMedicalDevice"
... value[x] 0..0 Value of extension

doco Documentation for this format

Snapshot View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Extension S 0..1 Extension Medizinprodukt
... id 0..1 string Unique id for inter-element referencing
... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:intendedPurpose S 0..1 Extension Zweckbestimmung
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... url 1..1 uri "intendedPurpose"
..... value[x] S 1..1 string Value of extension
.... extension:isMedicalDevice S 0..1 Extension Medizinprodukt
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... url 1..1 uri "isMedicalDevice"
..... value[x] S 0..1 boolean Value of extension
.... extension:notifiedBody S 0..1 Extension Benannte Stelle
..... id 0..1 string Unique id for inter-element referencing
..... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
...... extension:code S 0..1 Extension Kennnummer
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
....... url 1..1 uri "code"
....... value[x] S 1..1 string Value of extension
...... extension:name S 0..1 Extension Name
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
....... url 1..1 uri "name"
....... value[x] S 1..1 string Value of extension
..... url 1..1 uri "notifiedBody"
.... extension:nursingBenefit S 0..1 Extension Pflegerischer Nutzen
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... url 1..1 uri "nursingBenefit"
..... value[x] S 1..1 string Value of extension
.... extension:regulatoryBasis S 0..1 Extension Regulatorische Grundlage
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... url 1..1 uri "regulatoryBasis"
..... value[x] S 1..1 code Value of extension
Binding: ValueSet for HealthAppRegulatoryBasis (required)
.... extension:riskClass S 0..1 Extension Risikoklasse
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... url 1..1 uri "riskClass"
..... value[x] S 1..1 code Value of extension
Binding: ValueSet for HealthAppRiskClass (required)
... url 1..1 uri "https://fhir.bfarm.de/StructureDefinition/HealthAppModuleMedicalDevice"

doco Documentation for this format

This structure is derived from Extension

Summary

Complex Extension:

  • intendedPurpose: string: Die (medizinische) Zweckbestimmung entsprechend den Angaben des Herstellers auf der Kennzeichnung, in der Gebrauchsanweisung oder dem Werbe- oder Verkaufsmaterial bzw. den Werbe- oder Verkaufsangaben.
  • isMedicalDevice: boolean: Gibt an ob es sich beim Modul der digitalen Anwendung um ein Medizinprodukt handelt.
  • code: string: Kennnummer der benannten Stelle.
  • name: string: Name der benannten Stelle.
  • nursingBenefit: string: Nur DiPA: Die Beschreibung des pflegerischen Nutzens nach § 9 DiPAV.
  • regulatoryBasis: code:
    • mdd: Medical Device Directive
    • mdr: Medical Device Regulation
  • riskClass: code: Die Angabe der Risikoklasse.

 

Other representations of profile: CSV, Excel, Schematron

Terminology Bindings

Path Status Usage ValueSet Version Source
Extension.extension:regulatoryBasis.​value[x] Base required ValueSet for HealthAppRegulatoryBasis 📦3.0.2-RC1 This IG
Extension.extension:riskClass.​value[x] Base required ValueSet for HealthAppRiskClass 📦3.0.2-RC1 This IG

Constraints

Id Grade Path(s) Description Expression
ele-1 error **ALL** elements All FHIR elements must have a @value or children hasValue() or (children().count() > id.count())
ext-1 error **ALL** extensions Must have either extensions or value[x], not both extension.exists() != value.exists()