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eudamed_api_openapi_3_1.yml
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openapi: 3.1.0
info:
title: EUDAMED API Documentation (unofficial)
description: |-
This is the unofficial API documentation for the EUDAMED API. EUDAMED is the European database of medical devices.
We at [OpenRegulatory](https://openregulatory.com) built a better EUDAMED, called [BEUDAMED](https://beudamed.com). While building it, we learned a thing or two about the EUDAMED data structure.
We share our findings here because we believe that this level of openness and transparency ultimately leads to technological progress, with beneficial second-order effects for the EU, medical device manufacturers and, most importantly, patients.
In the past, these values led us to publish all our [MDR / ISO 13485 templates](https://openregulatory.com/templates) for free which are nowadays used by hundreds of companies (and known by Notified Bodies) and have enabled medical device manufacturers to enter the market at a much lower cost.
license:
name: MIT License
url: https://opensource.org/license/mit
version: "0.1"
externalDocs:
description: View on GitHub
url: http://github.com/openregulatory/eudamed-api
servers:
- url: https://ec.europa.eu/tools/eudamed/api
tags:
- name: devices
description: Endpoint for devices
- name: actors
description: Endpoint for actors (manufacturers, importers, etc.)
paths:
/devices/udiDiData:
get:
tags:
- devices
summary: List devices based on a search query
description: This is the endpoint used by the UI when you perform a device search. Note that it also works when the search query is empty. In simple terms, this returns the list of devices which are displayed by the UI. Most importantly, that list is in the `content` key of the response. Other useful pagination data is returned, too, e.g. `first`, `last` and `totalPages`.
operationId: listDevices
parameters:
- name: page
in: query
description: The page number of results which should be returned. Starts at 1.
required: true
schema:
type: integer
- name: pageSize
in: query
description: The count of results which should be returned per page. Maximum of 300 (the options shown in the EU are less).
required: true
schema:
type: integer
- name: size
in: query
description: Another parameter about the count of results per page. Seems to be a duplicate of `pageSize`. Not sure which one overrides which.
required: true
schema:
type: integer
- name: iso2Code
in: query
description: Probably the language of results which should be returned. Commonly `en`.
required: true
schema:
type: string
- name: languageIso2Code
in: query
description: Probalby another parameter about the language of results to be returned, seems to be a duplicate of `iso2Code`. Not sure which one overrides which. Commonly `en`.
required: true
schema:
type: string
responses:
'200':
description: Successful operation
content:
application/json:
schema:
$ref: '#/components/schemas/UdiDiDataList'
/devices/udiDiData/{deviceId}:
get:
tags:
- devices
summary: Get more data for a specific device
description: "This is the endpoint used by the UI when you click on a specific device. Things get a bit messy here: First off, the device data returned by this endpoint *looks* similar like the list data returned by the search endpoint above. However, the data here is more detailed. Additionally, the UI actually performs *two* API queries here - the second one hits the `basicUdiData` endpoint (below) which provides *additional* data for this level. Think of it this way: This endpoint provides data for a specific *device version* (e.g. v1.0 of a software device); the `basicUdiDi` endpoint below provides data spanning *across all versions of the device* (e.g. all versions of a software device in general). Confusing."
operationId: showDevice
parameters:
- name: deviceId
in: path
description: ID of device to return
required: true
schema:
type: string
format: uuid
- name: languageIso2Code
in: query
description: Probably the language of what to return. Commonly `en`.
required: true
schema:
type: string
responses:
'200':
description: Successful operation
content:
application/json:
schema:
$ref: '#/components/schemas/UdiDiData'
/devices/basicUdiData/{basicUdiDiId}:
get:
tags:
- devices
summary: Get data for a specific, umm.. higher-level device? The UDI stuff is confusing.
description: This is the *second* endpoint which is queried by the UI when you navigate to a device detail page. It contains *even more* additional device data, i.e. more device data than the other device endpoint (used in the same view), and more data than when you search. The context here is probably that a "Basic UDI-DI" is something of a higher-level identifier, i.e. it contains information valid across device versions. This is in contrast to the device endpoint which might only contain data for *one specific* device version.
operationId: showBasicUdiDi
parameters:
- name: basicUdiDiId
in: path
description: ID of device to return
required: true
schema:
type: string
format: uuid
- name: languageIso2Code
in: query
description: Probably the language of what to return. Commonly `en`.
required: true
schema:
type: string
responses:
'200':
description: Successful operation
content:
application/json:
schema:
$ref: '#/components/schemas/BasicUdiDiData'
/actors/{actorId}/publicInformation:
get:
tags:
- actors
summary: Get data for a specific actor (manufacturer, importer, etc.)
description: This is the endpoint used by the UI when you click on a specific actor (e.g. manufacturer, importer, etc.). Like with devices (= `udiDiData`), this endpoint provides more data on an actor than its search endpoint.
operationId: showActor
parameters:
- name: actorId
in: path
description: ID of actor to return
required: true
schema:
type: string
format: uuid
- name: languageIso2Code
in: query
description: Probably the language of what to return. Commonly `en`.
required: true
schema:
type: string
responses:
'200':
description: Successful operation
content:
application/json:
schema:
$ref: '#/components/schemas/Actor'
components:
schemas:
UdiDiDataList:
type: object
description: The object returned when you perform a device search. Most importantly, it contains the list of displayed devices in the `content` key.
properties:
content:
type: array
description: The search results (= devices).
items:
$ref: '#/components/schemas/UdiDiDataListEntry'
first:
type: boolean
description: Indicates if this is the first page of results.
last:
type: boolean
description: Indicates if this is the last page of results.
number:
type: integer
description: The current page number (starts at `1`).
numberOfElements:
type: integer
description: The number of elements in the current page.
size:
type: integer
description: The requested size of each page. Not sure.
sort:
type: object
description: Sorting information. Not sure how this works.
totalElements:
type: integer
description: The total number of elements across all pages. Not sure.
totalPages:
type: integer
description: The total number of pages.
UdiDiDataListEntry:
type: object
description: This is one entry in the search results provided by `UdiDiDataList`, specifically in the `content` key there. It contains basic device information, but less device information than the dedicated device endpoints (see below).
properties:
basicUdi:
type: string
description: The Basic UDI-DI identifier.
primaryDi:
type: string
description: The primary Device Identifier.
uuid:
type: string
format: uuid
description: ID of the device. This seems to be an internal and unique value within the Eudamed database.
ulid:
type: string
description: Another identifier for the device. No clue how its purpose differs from `uuid`.
basicUdiDiDataUlid:
type: string
description: Same here. Another identifier, no clue what its purpose is.
riskClass:
type: object
properties:
code:
type: string
description: Code representing the risk class of the device. It's an enum, see the options below. The slightly confusing part here is that legacy (e.g. MDD) and current (e.g. MDR) devices share the same risk classes - e.g. a class I MDD device would have the same enum value like a class I MDR device, even though the classification rules for those are different.
enum:
- refdata.risk-class.class-i
- refdata.risk-class.class-iia
- refdata.risk-class.class-iib
- refdata.risk-class.class-iii
- refdata.risk-class.ivd-general
- refdata.risk-class.class-a
- refdata.risk-class.class-b
- refdata.risk-class.class-c
- refdata.risk-class.class-d
- refdata.risk-class.ivd-annex-ii-list-a
- refdata.risk-class.ivd-annex-ii-list-b
- refdata.risk-class.ivd-devices-self-testing
- refdata.risk-class.aimdd
tradeName:
type: string
description: The trade name or brand name of the device. Either here or somewhere else, sometimes multiple names for different languages can be entered as an array of object. Not sure.
manufacturerName:
type: string
description: Name of the device manufacturer. Note how this starts duplicating the data of the `Manufacturer` object further below. It starts getting confusing.
manufacturerSrn:
type: string
description: Single Registration Number (SRN) of the manufacturer. Partial duplication of `Manufacturer` object.
deviceStatusType:
type: object
properties:
code:
type: string
description: Enum representing the status of the device.
enum:
- refdata.device-model-status.on-the-market
- refdata.device-model-status.no-longer-on-the-market
- refdata.device-model-status.not-intended-for-eu-market
manufacturerStatus:
type: object
properties:
code:
type: string
description: Code representing the status of the manufacturer. Again, likely duplication of data in the `Manufacturer` object.
latestVersion:
type: boolean
description: Indicates if this is the latest version of the device data. It seems device data is versioned, but it's not clear how to query for specific (old) versions of the data.
versionNumber:
type: integer
description: Version number of the device data.
reference:
type: string
description: Reference code or number for the device. No clue what this is.
authorisedRepresentativeSrn:
type: string
description: SRN of the authorized representative. Similar as for `Manufacturer`, there's duplication here again, because `AuthorizedRepresentative` is actually its own object (further below), but only some of those keys are copied over here. Ugh.
authorisedRepresentativeName:
type: string
description: Name of the authorized representative. Same note as above.
UdiDiData:
type: object
description: "This is the more detailed data returned when visiting the detail page of a device. Note that this is only one of two parts: The second part of the device data is the `BasicUdiData`, see below."
properties:
uuid:
type: string
format: uuid
description: ID of the device. This seems to be an internal and unique value within the Eudamed database. If I remember correctly, this corresponds to the `uuid` returned by the search results above.
ulid:
type: string
description: Another identifier for the device. No clue how its purpose differs from `uuid`.
primaryDi:
type: object
description: Things start getting confusing here. Some UDI information.
properties:
uuid:
type: string
format: uuid
code:
type: string
issuingAgency:
type: object
properties:
code:
type: string
type:
type: string
new:
type: boolean
containedItem:
type: object
description: No clue.
marketInfoLink:
type: object
description: Generally speaking, this seems to contain information about which countries this device is available in. The data looks really clunky.
properties:
uuid:
type: string
format: uuid
ulid:
type: string
msWhereAvailable:
type: array
items:
type: object
properties:
uuid:
type: string
format: uuid
marketInfoLinkId:
type: integer
country:
type: object
properties:
name:
type: string
type:
type: string
iso2Code:
type: string
nonEUMemberState:
type: boolean
startDate:
type: string
endDate:
type: string
new:
type: boolean
versionState:
type: object
properties:
code:
type: string
latestVersion:
type: boolean
versionNumber:
type: integer
discardedDate:
type: string
versionDate:
type: string
format: date-time
new:
type: boolean
secondaryDi:
type: object
description: No clue. UDIs are a mess.
secondaryDiApplicable:
type: boolean
description: It gets worse.
additionalDescription:
type: string
description: What the hell is an additional description?
tradeName:
type: object
description: Trade names in different languages. Confusing.
properties:
texts:
type: array
items:
type: object
properties:
language:
type: object
text:
type: string
allLanguagesApplicable:
type: boolean
tradeNameApplicable:
type: boolean
description: No clue.
annexXVIApplicable:
type: boolean
description: Some regulatory information.
brainElectroStimulation:
type: boolean
description: One of many (many!) booleans about device characteristics.
cmrSubstance:
type: boolean
description: One of many (many!) booleans about device characteristics.
cmrSubstances:
type: array
description: Somehow related to `cmrSubstance` and likely contains an array of things, but no clue what those might be.
items: {}
componentDis:
type: array
description: No clue.
items: {}
contactLenses:
type: boolean
description: "One of many (many!) booleans about device characteristics. It gets even more confusing for this one because the UI shows something about \"soft\" contact lenses, but in the data you only have the key `contactLenses`."
directMarking:
type: boolean
description: One of many (many!) booleans about device characteristics.
directMarkingSameAsUdiDi:
type: boolean
description: One of many (many!) booleans about device characteristics.
directMarkingDi:
type: object
description: No clue.
emr:
type: boolean
description: One of many (many!) booleans about device characteristics.
endocrineDisruptingSubstances:
type: array
description: Somehow related to `endocrineDisruptor` and likely contains an array, but no clue about the structure of its items.
items: {}
endocrineDisruptor:
type: boolean
description: One of many (many!) booleans about device characteristics.
equipmentForAdiposeTissue:
type: boolean
description: One of many (many!) booleans about device characteristics.
fillingByInjection:
type: boolean
description: One of many (many!) booleans about device characteristics.
humanProductSubstances:
type: array
description: No clue.
items: {}
latex:
type: boolean
description: One of many (many!) booleans about device characteristics.
udiPiType:
type: object
description: UDIs are a mess.
properties:
batchNumber:
type: boolean
serializationNumber:
type: boolean
manufacturingDate:
type: boolean
expirationDate:
type: boolean
softwareIdentification:
type: boolean
medicinalProductSubstances:
type: array
description: No clue.
items: {}
cndNomenclatures:
type: array
items:
type: object
properties:
uuid:
type: string
code:
type: string
description:
type: object
properties:
texts:
type: array
items:
type: object
properties:
language:
type: object
properties:
isoCode:
type: string
name:
type: string
text:
type: string
allLanguagesApplicable:
type: boolean
gmdnNomenclatures:
type: array
items: {}
oemApplicable:
type: boolean
description: One of many (many!) booleans about device characteristics.
productDesigner:
type: object
placedOnTheMarket:
type: object
description: When and where this device was placed on the market.
properties:
name:
type: string
type:
type: string
iso2Code:
type: string
nonEUMemberState:
type: boolean
productsToBeIntroduced:
type: object
description: No clue.
reference:
type: string
description: No clue.
reprocessed:
type: boolean
description: One of many (many!) booleans about device characteristics.
maxNumberOfReuses:
type: integer
maxNumberOfReusesApplicable:
type: boolean
description: One of many (many!) booleans about device characteristics.
singleUse:
type: boolean
description: One of many (many!) booleans about device characteristics.
clinicalSizeApplicable:
type: boolean
description: One of many (many!) booleans about device characteristics.
clinicalSizes:
type: array
items: {}
deviceStatus:
type: object
properties:
uuid:
type: string
format: uuid
type:
type: object
properties:
code:
type: string
enum:
- refdata.device-model-status.on-the-market
- refdata.device-model-status.no-longer-on-the-market
- refdata.device-model-status.not-intended-for-eu-market
statusDate:
type: string
format: date
new:
type: boolean
subStatuses:
type: array
items: {}
sterile:
type: boolean
description: One of many (many!) booleans about device characteristics.
sterilization:
type: boolean
description: One of many (many!) booleans about device characteristics.
storageApplicable:
type: boolean
description: One of many (many!) booleans about device characteristics.
storageHandlingConditions:
type: array
items: {}
unitOfUse:
type: object
criticalWarningsApplicable:
type: boolean
criticalWarnings:
type: array
items: {}
additionalInformationUrl:
type: string
storageSymbol:
type: object
baseQuantity:
type: integer
versionDate:
type: string
format: date-time
versionState:
type: object
properties:
code:
type: string
latestVersion:
type: boolean
versionNumber:
type: integer
newDevice:
type: boolean
discardedDate:
type: string
linkedUdiDiView:
type: object
new:
type: boolean
BasicUdiDiData:
type: object
description: So you probably already thought that the `UdiDiData` was lengthy and looked rather messy. Well, good luck, because you're only half done as there's another object which contains even more device data - this one.
properties:
uuid:
type: string
description: ID of the `BasicUdiDi` entry. Note that this differs from the `uuid` of the `UdiDiEntry` above. So you need *two* uuids to query all information for a device.
format: uuid
ulid:
type: string
udiDiData:
type: object
manufacturer:
description: Data on the manufacturer. In contrast to the `UdiDiData` endpoint further above, this actually contains the complete information on the manufacturer and not only a weird slice of it.
$ref: '#/components/schemas/Actor'
authorisedRepresentative:
description: Data on the authorized representative. In contrast to the `UdiDiData` endpoint further above, this actually contains the complete information on the authorized representative and not only a weird slice of it.
$ref: '#/components/schemas/AuthorizedRepresentative'
active:
type: boolean
description: One of many (many!) booleans about device characteristics.
administeringMedicine:
type: boolean
description: One of many (many!) booleans about device characteristics.
animalTissues:
type: boolean
description: One of many (many!) booleans about device characteristics.
nbDecision:
type: object
basicUdi:
type: object
properties:
uuid:
type: string
format: uuid
code:
type: string
issuingAgency:
type: object
properties:
code:
type: string
type:
type: string
new:
type: boolean
companionDiagnostics:
type: boolean
description: One of many (many!) booleans about device characteristics.
reagent:
type: boolean
description: One of many (many!) booleans about device characteristics.
instrument:
type: boolean
description: One of many (many!) booleans about device characteristics.
professionalTesting:
type: boolean
description: One of many (many!) booleans about device characteristics.
kit:
type: boolean
description: One of many (many!) booleans about device characteristics.
device:
type: boolean
multiComponent:
type: boolean
description: One of many (many!) booleans about device characteristics.
deviceCriterion:
type: string
basicUdiType:
type: object
deviceModel:
type: string
deviceModelApplicable:
type: boolean
description: One of many (many!) booleans about device characteristics.
deviceName:
type: string
humanTissues:
type: boolean
description: One of many (many!) booleans about device characteristics.
humanProduct:
type: boolean
description: One of many (many!) booleans about device characteristics.
medicinalProduct:
type: boolean
description: One of many (many!) booleans about device characteristics.
implantable:
type: boolean
description: One of many (many!) booleans about device characteristics.
sutures:
type: object
legislation:
type: object
properties:
code:
type: string
enum:
- refdata.applicable-legislation.mdd
- refdata.applicable-legislation.mdr
- refdata.applicable-legislation.ivdd
- refdata.applicable-legislation.ivdr
- refdata.applicable-legislation.aimdd
legacyDirective:
type: boolean
measuringFunction:
type: boolean
description: One of many (many!) booleans about device characteristics.
microbialSubstances:
type: boolean
description: One of many (many!) booleans about device characteristics.
nearPatientTesting:
type: boolean
description: One of many (many!) booleans about device characteristics.
reusable:
type: boolean
description: One of many (many!) booleans about device characteristics.
riskClass:
type: object
properties:
code:
type: string
description: The risk class of this device. Note that the risk class is stored here, with the `BasicUdiDiData`, and not with the actual device, i.e. in the `UdiDiData`. Confusing.
enum:
- refdata.risk-class.class-i
- refdata.risk-class.class-iia
- refdata.risk-class.class-iib
- refdata.risk-class.class-iii
- refdata.risk-class.ivd-general
- refdata.risk-class.class-a
- refdata.risk-class.class-b
- refdata.risk-class.class-c
- refdata.risk-class.class-d
- refdata.risk-class.ivd-annex-ii-list-a
- refdata.risk-class.ivd-annex-ii-list-b
- refdata.risk-class.ivd-devices-self-testing
- refdata.risk-class.aimdd
selfTesting:
type: boolean
description: One of many (many!) booleans about device characteristics.
specialDeviceType:
type: object
description: "So as you've seen, many device characteristics are modeled as booleans. So far, so good. But it gets really confusing now. Two special device types exist: Software and orthopedic devices (of all things). So if a device is software or an orthopedic device, the value here is set to a specific enum. This has surprising and very weird consequences, e.g. a device can't be both software and orthopedic. Weird. Why?"
properties:
code:
type: string
enum:
- refdata.special-mdd-device-type.software
- refdata.special-mdr-device-type.software
- refdata.special-ivdd-device-type.software
- refdata.special-ivd-device-type.software
- refdata.special-mdd-device-type.orthopedic
- refdata.special-mdr-device-type.orthopedic
specialDeviceTypeApplicable:
type: boolean
description: One of many (many!) booleans about device characteristics.
medicalPurpose:
type: object
description: The intended use of the device. Often not provided even though this seems like kinda important information, chuckle..
typeExaminationApplicable:
type: boolean
description: One of many (many!) booleans about device characteristics.
deviceCertificateInfoList:
type: array
description: The list of certificates for this device. Also contains the notified body which issued each certificate.
items:
$ref: '#/components/schemas/DeviceCertificateInfo'
deviceCertificateInfoListForDisplay:
type: array
description: What a mess. Seems to contain the exact same values as `deviceCertificateInfoList`, but someone thought it'd be a create idea to create another key and append `ForDisplay` to it.
items:
$ref: '#/components/schemas/DeviceCertificateInfo'
clinicalInvestigationApplicable:
type: boolean
description: One of many (many!) booleans about device characteristics.
clinicalInvestigationLinks:
type: array
items: {}
versionDate:
type: string
format: date-time
versionState:
type: object
properties:
code:
type: string
latestVersion:
type: boolean
versionNumber:
type: integer
legacyDeviceUdiDiApplicable:
type: boolean
description: One of many (many!) booleans about device characteristics.
discardedDate:
type: string
linkedSscp:
$ref: '#/components/schemas/LinkedSscp'
new:
type: boolean
DeviceCertificateInfo:
type: object
description: This is a certificate entry in the `BasicUdiDiData` endpoint. It contains certificate information for a device, and the notified body which issued it.
properties:
uuid:
type: string
format: uuid
ulid:
type: string
certificateExpiry:
type: string
format: date
certificateNumber:
type: string
certificateRevision:
type: string
notifiedBody:
$ref: '#/components/schemas/NotifiedBody'
certificateType:
type: object
properties:
code:
type: string
versionState:
type: object
properties:
code:
type: string
latestVersion:
type: boolean
versionNumber:
type: integer
discardedDate:
type: string
issueDate:
type: string
format: date
status:
type: object
properties:
code:
type: string
nbProvidedCertificate:
type: boolean
startingValidityDate:
type: string
format: date
new:
type: boolean
NotifiedBody:
type: object
description: The notified body which issued a certificate.
properties:
uuid:
type: string
format: uuid
ulid:
type: string
versionNumber:
type: integer
versionState:
type: object
properties:
code:
type: string
latestVersion:
type: boolean
lastUpdateDate:
type: string
format: date-time
name:
type: string
names:
type: object
properties:
texts:
type: array
items:
type: object
properties:
language:
type: object
text:
type: string
allLanguagesApplicable:
type: boolean
abbreviatedNames:
type: object
properties:
texts:
type: array
items:
type: object
properties:
language:
type: object
text:
type: string
allLanguagesApplicable:
type: boolean
actorType:
type: object
properties:
code:
type: string
srnCode:
type: string
category:
type: string
status:
type: object
properties:
code:
type: string
statusFromDate:
type: string
countryIso2Code:
type: string
countryName:
type: string
countryType:
type: string
geographicalAddress:
type: string
electronicMail:
type: string
telephone:
type: string
srn:
type: string
LinkedSscp:
type: object
properties:
ulid:
type: string
validated:
type: boolean
uuid:
type: string
format: uuid
referenceNumber:
type: string
revisionNumber:
type: string
issueDate:
type: string
format: date
versionNumber:
type: integer
inactive:
type: boolean
inactiveStatusDate:
type: string
Actor:
type: object
description: An actor is typically a manufacturer or importer.
properties:
importers:
type: array
items: {}
nonEuManufacturers:
type: object
actorDataPublicView:
type: object
description: No clue why any sane developer would put all relevant data in a `actorDataPublicView` key. Like.. is the other public data not for public viewing?
properties:
ulid:
type: string
uuid:
type: string
format: uuid
type:
type: object
properties:
code:
type: string
enum:
- refdata.actor-type.manufacturer
srnCode:
type: string
category:
type: string
actorStatus:
type: object
properties:
code:
type: string
enum:
- refdata.actor-status.active
actorStatusFromDate:
type: string
country:
type: object
properties:
name:
type: string
type:
type: string
iso2Code:
type: string
nonEUMemberState:
type: boolean
name:
type: object
properties:
texts:
type: array