BfArM Digitale Anwendungen
3.1.0-TEST - draft

​BfArM Digitale Anwendungen - Local Development build (v3.1.0-TEST) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions

Extension: HealthAppModule: MedicalDevice

Official URL: https://fhir.bfarm.de/StructureDefinition/HealthAppModuleMedicalDevice Version: 3.1.0-TEST
Active as of 2026-05-30 Computable Name: HealthAppModuleMedicalDevice

Extension for information about the medical device.

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..* Extension Medical device
... extension S 0..* Extension Extension
... Slices for extension Content/Rules for all slices
.... extension:intendedPurpose S 0..1 Extension Intended purpose
..... extension 0..0 Extension
..... url 1..1 uri "intendedPurpose"
..... Slices for value[x] 1..1 string Value of extension
Slice: Unordered, Open by type:$this
...... value[x]:valueString S 1..1 string Value of extension
.... extension:isMedicalDevice S 0..1 Extension Medical device
..... extension 0..0 Extension
..... url 1..1 uri "isMedicalDevice"
..... Slices for value[x] 1..1 boolean Value of extension
Slice: Unordered, Open by type:$this
...... value[x]:valueBoolean S 1..1 boolean Value of extension
.... extension:notifiedBody S 0..1 Extension Notified body
..... extension S 0..* Extension Extension
..... Slices for extension Content/Rules for all slices
...... extension:code S 0..1 Extension Identification number
....... extension 0..0 Extension
....... url 1..1 uri "code"
....... Slices for value[x] 1..1 string Value of extension
Slice: Unordered, Open by type:$this
........ value[x]:valueString S 1..1 string Value of extension
...... extension:name S 0..1 Extension Name
....... extension 0..0 Extension
....... url 1..1 uri "name"
....... Slices for value[x] 1..1 string Value of extension
Slice: Unordered, Open by type:$this
........ value[x]:valueString 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 Nursing benefit
..... extension 0..0 Extension
..... url 1..1 uri "nursingBenefit"
..... Slices for value[x] 1..1 string Value of extension
Slice: Unordered, Open by type:$this
...... value[x]:valueString S 1..1 string Value of extension
.... extension:regulatoryBasis S 0..1 Extension Regulatory basis
..... extension 0..0 Extension
..... url 1..1 uri "regulatoryBasis"
..... Slices for value[x] 1..1 code Value of extension
Slice: Unordered, Open by type:$this
...... value[x]:valueCode S 1..1 code Value of extension
Binding: HealthAppRegulatoryBasis (required)
.... extension:riskClass S 0..1 Extension Risk class
..... extension 0..0 Extension
..... url 1..1 uri "riskClass"
..... Slices for value[x] 1..1 code Value of extension
Slice: Unordered, Open by type:$this
...... value[x]:valueCode S 1..1 code Value of extension
Binding: HealthAppRiskClass (required)
... url 1..1 uri "https://fhir.bfarm.de/StructureDefinition/HealthAppModuleMedicalDevice"

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Extension S 0..* Extension Medical device
... id 0..1 string Unique id for inter-element referencing
... Slices for extension S 0..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:intendedPurpose S 0..1 Extension Intended purpose
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url 1..1 uri "intendedPurpose"
..... Slices for value[x] 1..1 string Value of extension
Slice: Unordered, Closed by type:$this
...... value[x]:valueString S 1..1 string Value of extension
.... extension:isMedicalDevice S 0..1 Extension Medical device
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url 1..1 uri "isMedicalDevice"
..... Slices for value[x] 1..1 boolean Value of extension
Slice: Unordered, Closed by type:$this
...... value[x]:valueBoolean S 1..1 boolean Value of extension
.... extension:notifiedBody S 0..1 Extension Notified body
..... id 0..1 string Unique id for inter-element referencing
..... Slices for extension S 0..* Extension Extension
Slice: Unordered, Open by value:url
...... extension:code S 0..1 Extension Identification number
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..0 Extension
Slice: Unordered, Open by value:url
....... url 1..1 uri "code"
....... Slices for value[x] 1..1 string Value of extension
Slice: Unordered, Closed by type:$this
........ value[x]:valueString S 1..1 string Value of extension
...... extension:name S 0..1 Extension Name
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..0 Extension
Slice: Unordered, Open by value:url
....... url 1..1 uri "name"
....... Slices for value[x] 1..1 string Value of extension
Slice: Unordered, Closed by type:$this
........ value[x]:valueString S 1..1 string Value of extension
..... url 1..1 uri "notifiedBody"
.... extension:nursingBenefit S 0..1 Extension Nursing benefit
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url 1..1 uri "nursingBenefit"
..... Slices for value[x] 1..1 string Value of extension
Slice: Unordered, Closed by type:$this
...... value[x]:valueString S 1..1 string Value of extension
.... extension:regulatoryBasis S 0..1 Extension Regulatory basis
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url 1..1 uri "regulatoryBasis"
..... Slices for value[x] 1..1 code Value of extension
Slice: Unordered, Closed by type:$this
...... value[x]:valueCode S 1..1 code Value of extension
Binding: HealthAppRegulatoryBasis (required)
.... extension:riskClass S 0..1 Extension Risk class
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url 1..1 uri "riskClass"
..... Slices for value[x] 1..1 code Value of extension
Slice: Unordered, Closed by type:$this
...... value[x]:valueCode S 1..1 code Value of extension
Binding: 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: Extension for information about the medical device.

  • intendedPurpose: string: The (medical) intended purpose according to the manufacturer's information on labeling, instructions for use, advertising material, sales material, or sales information.
  • isMedicalDevice: boolean: Indicates whether the digital application module is a medical device.
  • code: string: Identification number of the notified body.
  • name: string: Name of the notified body.
  • nursingBenefit: string: DiPA only: Description of the nursing benefit according to § 9 DiPAV.
  • regulatoryBasis: code: Specifies the regulatory basis.
  • riskClass: code: Specifies the risk class.

Differential View

This structure is derived from Extension

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Extension S 0..* Extension Medical device
... extension S 0..* Extension Extension
... Slices for extension Content/Rules for all slices
.... extension:intendedPurpose S 0..1 Extension Intended purpose
..... extension 0..0 Extension
..... url 1..1 uri "intendedPurpose"
..... Slices for value[x] 1..1 string Value of extension
Slice: Unordered, Open by type:$this
...... value[x]:valueString S 1..1 string Value of extension
.... extension:isMedicalDevice S 0..1 Extension Medical device
..... extension 0..0 Extension
..... url 1..1 uri "isMedicalDevice"
..... Slices for value[x] 1..1 boolean Value of extension
Slice: Unordered, Open by type:$this
...... value[x]:valueBoolean S 1..1 boolean Value of extension
.... extension:notifiedBody S 0..1 Extension Notified body
..... extension S 0..* Extension Extension
..... Slices for extension Content/Rules for all slices
...... extension:code S 0..1 Extension Identification number
....... extension 0..0 Extension
....... url 1..1 uri "code"
....... Slices for value[x] 1..1 string Value of extension
Slice: Unordered, Open by type:$this
........ value[x]:valueString S 1..1 string Value of extension
...... extension:name S 0..1 Extension Name
....... extension 0..0 Extension
....... url 1..1 uri "name"
....... Slices for value[x] 1..1 string Value of extension
Slice: Unordered, Open by type:$this
........ value[x]:valueString 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 Nursing benefit
..... extension 0..0 Extension
..... url 1..1 uri "nursingBenefit"
..... Slices for value[x] 1..1 string Value of extension
Slice: Unordered, Open by type:$this
...... value[x]:valueString S 1..1 string Value of extension
.... extension:regulatoryBasis S 0..1 Extension Regulatory basis
..... extension 0..0 Extension
..... url 1..1 uri "regulatoryBasis"
..... Slices for value[x] 1..1 code Value of extension
Slice: Unordered, Open by type:$this
...... value[x]:valueCode S 1..1 code Value of extension
Binding: HealthAppRegulatoryBasis (required)
.... extension:riskClass S 0..1 Extension Risk class
..... extension 0..0 Extension
..... url 1..1 uri "riskClass"
..... Slices for value[x] 1..1 code Value of extension
Slice: Unordered, Open by type:$this
...... value[x]:valueCode S 1..1 code Value of extension
Binding: HealthAppRiskClass (required)
... url 1..1 uri "https://fhir.bfarm.de/StructureDefinition/HealthAppModuleMedicalDevice"

doco Documentation for this format

Snapshot View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Extension S 0..* Extension Medical device
... id 0..1 string Unique id for inter-element referencing
... Slices for extension S 0..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:intendedPurpose S 0..1 Extension Intended purpose
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url 1..1 uri "intendedPurpose"
..... Slices for value[x] 1..1 string Value of extension
Slice: Unordered, Closed by type:$this
...... value[x]:valueString S 1..1 string Value of extension
.... extension:isMedicalDevice S 0..1 Extension Medical device
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url 1..1 uri "isMedicalDevice"
..... Slices for value[x] 1..1 boolean Value of extension
Slice: Unordered, Closed by type:$this
...... value[x]:valueBoolean S 1..1 boolean Value of extension
.... extension:notifiedBody S 0..1 Extension Notified body
..... id 0..1 string Unique id for inter-element referencing
..... Slices for extension S 0..* Extension Extension
Slice: Unordered, Open by value:url
...... extension:code S 0..1 Extension Identification number
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..0 Extension
Slice: Unordered, Open by value:url
....... url 1..1 uri "code"
....... Slices for value[x] 1..1 string Value of extension
Slice: Unordered, Closed by type:$this
........ value[x]:valueString S 1..1 string Value of extension
...... extension:name S 0..1 Extension Name
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..0 Extension
Slice: Unordered, Open by value:url
....... url 1..1 uri "name"
....... Slices for value[x] 1..1 string Value of extension
Slice: Unordered, Closed by type:$this
........ value[x]:valueString S 1..1 string Value of extension
..... url 1..1 uri "notifiedBody"
.... extension:nursingBenefit S 0..1 Extension Nursing benefit
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url 1..1 uri "nursingBenefit"
..... Slices for value[x] 1..1 string Value of extension
Slice: Unordered, Closed by type:$this
...... value[x]:valueString S 1..1 string Value of extension
.... extension:regulatoryBasis S 0..1 Extension Regulatory basis
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url 1..1 uri "regulatoryBasis"
..... Slices for value[x] 1..1 code Value of extension
Slice: Unordered, Closed by type:$this
...... value[x]:valueCode S 1..1 code Value of extension
Binding: HealthAppRegulatoryBasis (required)
.... extension:riskClass S 0..1 Extension Risk class
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..0 Extension
Slice: Unordered, Open by value:url
..... url 1..1 uri "riskClass"
..... Slices for value[x] 1..1 code Value of extension
Slice: Unordered, Closed by type:$this
...... value[x]:valueCode S 1..1 code Value of extension
Binding: 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: Extension for information about the medical device.

  • intendedPurpose: string: The (medical) intended purpose according to the manufacturer's information on labeling, instructions for use, advertising material, sales material, or sales information.
  • isMedicalDevice: boolean: Indicates whether the digital application module is a medical device.
  • code: string: Identification number of the notified body.
  • name: string: Name of the notified body.
  • nursingBenefit: string: DiPA only: Description of the nursing benefit according to § 9 DiPAV.
  • regulatoryBasis: code: Specifies the regulatory basis.
  • riskClass: code: Specifies the risk class.

 

Other representations of profile: CSV, Excel, Schematron

Terminology Bindings

Path Status Usage ValueSet Version Source
Extension.extension:regulatoryBasis.​value[x]:valueCode Base required HealthAppRegulatoryBasis 📦3.1.0-TEST This IG
Extension.extension:riskClass.​value[x]:valueCode Base required HealthAppRiskClass 📦3.1.0-TEST 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()