EUDAMED MDR Submit - UDI Hub User Guide

curl --request POST \
  --url https://api.udiconnect.io/api/v1/submit/EU_UDI_MDR \
  --header 'Authorization: <api-key>' \
  --header 'Content-Type: application/json' \
  --data '
"{\n  \"actorCode\": \"DE-MF-000001723\",\n  \"device\": {\n    \"IssuingAgency\": \"GS1\",\n    \"Device\": \"00308676965723\",\n    \"DeviceGroup\": \"439990237188JM\",\n    \"Material\": \"37588-474\",\n    \"BaseQuantity\": 1,\n    \"CommercialDistributionStatus\": \"ON_THE_MARKET\",\n    \"ProductionIdentifier\": [\n      \"BATCH_NUMBER\"\n    ],\n    \"ReferenceNumber\": \"37588-474\",\n    \"MDN\": [\n      \"A0101010201\"\n    ],\n    \"NumberOfReuses\": 0,\n    \"ContainsLatex\": false,\n    \"Reprocessed\": false,\n    \"Sterile\": false,\n    \"ReqSterilizatonPriorUse\": true,\n    \"MarketInfos\": [\n      {\n        \"Country\": \"DE\",\n        \"OriginalPlacedOnTheMarket\": true\n      }\n    ],\n    \"AdditionalTradeNames\": [\n      {\n        \"AdditionalTradeName\": \"Trade Name\",\n        \"AdditionalTradeNameLanguage\": \"EN\"\n      }\n    ]\n  },\n  \"deviceGroup\": {\n    \"DeviceGroupAgency\": \"GS1\",\n    \"DeviceGroup\": \"439990237188JM\",\n    \"ApplicableLegislation\": \"MDR\",\n    \"MFActorCode\": \"DE-MF-000001723\",\n    \"DeviceName\": \"Device Name\",\n    \"RiskClass\": \"CLASS_I\",\n    \"AnimalTissuesCells\": false,\n    \"HumanTissuesCells\": false,\n    \"DeviceImplantable\": false,\n    \"DeviceHasMeasuringFunction\": false,\n    \"DeviceReusableSurgicalInstrument\": false,\n    \"ActiveDevice\": false,\n    \"DeviceIntendedToAdministerMedicine\": false,\n    \"SystemDevice\": false,\n    \"ProcedurePackDevice\": false,\n    \"HumanProductCheck\": false,\n    \"MedicinalProductCheck\": false\n  }\n}\n"
'

"{\n  \"agency\": \"EC\",\n  \"requestId\": \"string\",\n  \"modelInformation\": \"string\",\n  \"status\": \"SUCCESS\",\n  \"statusText\": \"Submission successfully validated and accepted\"\n}"

"{\n  \"status\": \"failed\",\n  \"message\": \"Validation failed\",\n  \"deviceErrors\": [\n    {\n      \"path\": \"string\",\n      \"message\": \"string\",\n      \"ruleId\": \"string\"\n    }\n  ],\n  \"deviceGroupErrors\": [\n    {\n      \"path\": \"string\",\n      \"message\": \"string\",\n      \"ruleId\": \"string\"\n    }\n  ]\n}"

"{\n  \"agency\": \"EC\",\n  \"requestId\": \"string\",\n  \"modelInformation\": \"string\",\n  \"status\": \"BLOCKED\",\n  \"statusText\": \"Submission blocked due to business rules\",\n  \"reasons\": [\n    \"Entity X is not submittable because of its current state (In Submission) \"\n  ]\n}"

"{\n  \"timestamp\": \"string\",\n  \"status\": 500,\n  \"error\": \"Internal Server Error\",\n  \"message\": \"string\"\n}"

POST

api

submit

EU_UDI_MDR

curl --request POST \
  --url https://api.udiconnect.io/api/v1/submit/EU_UDI_MDR \
  --header 'Authorization: <api-key>' \
  --header 'Content-Type: application/json' \
  --data '
"{\n  \"actorCode\": \"DE-MF-000001723\",\n  \"device\": {\n    \"IssuingAgency\": \"GS1\",\n    \"Device\": \"00308676965723\",\n    \"DeviceGroup\": \"439990237188JM\",\n    \"Material\": \"37588-474\",\n    \"BaseQuantity\": 1,\n    \"CommercialDistributionStatus\": \"ON_THE_MARKET\",\n    \"ProductionIdentifier\": [\n      \"BATCH_NUMBER\"\n    ],\n    \"ReferenceNumber\": \"37588-474\",\n    \"MDN\": [\n      \"A0101010201\"\n    ],\n    \"NumberOfReuses\": 0,\n    \"ContainsLatex\": false,\n    \"Reprocessed\": false,\n    \"Sterile\": false,\n    \"ReqSterilizatonPriorUse\": true,\n    \"MarketInfos\": [\n      {\n        \"Country\": \"DE\",\n        \"OriginalPlacedOnTheMarket\": true\n      }\n    ],\n    \"AdditionalTradeNames\": [\n      {\n        \"AdditionalTradeName\": \"Trade Name\",\n        \"AdditionalTradeNameLanguage\": \"EN\"\n      }\n    ]\n  },\n  \"deviceGroup\": {\n    \"DeviceGroupAgency\": \"GS1\",\n    \"DeviceGroup\": \"439990237188JM\",\n    \"ApplicableLegislation\": \"MDR\",\n    \"MFActorCode\": \"DE-MF-000001723\",\n    \"DeviceName\": \"Device Name\",\n    \"RiskClass\": \"CLASS_I\",\n    \"AnimalTissuesCells\": false,\n    \"HumanTissuesCells\": false,\n    \"DeviceImplantable\": false,\n    \"DeviceHasMeasuringFunction\": false,\n    \"DeviceReusableSurgicalInstrument\": false,\n    \"ActiveDevice\": false,\n    \"DeviceIntendedToAdministerMedicine\": false,\n    \"SystemDevice\": false,\n    \"ProcedurePackDevice\": false,\n    \"HumanProductCheck\": false,\n    \"MedicinalProductCheck\": false\n  }\n}\n"
'

"{\n  \"agency\": \"EC\",\n  \"requestId\": \"string\",\n  \"modelInformation\": \"string\",\n  \"status\": \"SUCCESS\",\n  \"statusText\": \"Submission successfully validated and accepted\"\n}"

"{\n  \"status\": \"failed\",\n  \"message\": \"Validation failed\",\n  \"deviceErrors\": [\n    {\n      \"path\": \"string\",\n      \"message\": \"string\",\n      \"ruleId\": \"string\"\n    }\n  ],\n  \"deviceGroupErrors\": [\n    {\n      \"path\": \"string\",\n      \"message\": \"string\",\n      \"ruleId\": \"string\"\n    }\n  ]\n}"

"{\n  \"agency\": \"EC\",\n  \"requestId\": \"string\",\n  \"modelInformation\": \"string\",\n  \"status\": \"BLOCKED\",\n  \"statusText\": \"Submission blocked due to business rules\",\n  \"reasons\": [\n    \"Entity X is not submittable because of its current state (In Submission) \"\n  ]\n}"

"{\n  \"timestamp\": \"string\",\n  \"status\": 500,\n  \"error\": \"Internal Server Error\",\n  \"message\": \"string\"\n}"

Authorizations

Authorization

string

header

required

Body

application/json

Data to be submitted

actorCode

string

securityToken

string

device

object

required for all EC submissions

Show child attributes

deviceGroup

object

required for all EC submissions if not already submitted & published

Show child attributes

Response

Submission processed successfully

Response for successful submission processing

agency

enum<string>

Regulatory agency information

Available options:

COMMON_DEVICE_DATA,

FDA,

EC,

NMPA,

MFDS,

GDSN,

SFDA,

TFDA,

TGA,

HSA

requestId

string

The unique identifier for the submission request

modelInformation

string

Information about the model and use case data used for processing the request

status

enum<string>

Submission response status

Available options:

INTERNAL_ERROR,

SUCCESS,

BLOCKED,

VALIDATION_FAILED

statusText

string

Description of the status

EUDAMED MDR Validate EUDAMED IVDR Validate

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