Annex 2 (XML files index)
Use case | Actors | XML file | Description | Result |
|---|---|---|---|---|
Download registered actors | CA, EO, NB | SAMPLE_DTX_ACT_001.01.xml | Search for an individual manufacturer SRN (EU and non- EU) | Positive |
SAMPLE_DTX_ACT_001.03.xml | Search for an individual importer | Positive | ||
SAMPLE_DTX_ACT_001.04.xml | Search for an individual authorised representative | Positive | ||
SAMPLE_DTX_ACT_001.05.xml | Search for an individual producer | Positive | ||
SAMPLE_DTX_ACT_001.07.xml | Request to download a registered economic operator using the wrong attribute type in the pull request | Negative | ||
Download actor registration requests | CA | SAMPLE_DTX_ACT_002.01.xml | Download a specific application ID (includes Zip attachment) | Positive |
SAMPLE_DTX_ACT_002.02.xml | Request containing incorrect end tag – XSD invalid | Negative | ||
SAMPLE_DTX_ACT_002.03.xml | Request a specific initial submission date with a mix of EU and non-EU Producers (includes Zip attachments) | Positive | ||
Upload actor registration request assessments | CA | SAMPLE_DTX_ACT_003.01.xml | Approve EU manufacturer | Positive |
SAMPLE_DTX_ACT_003.02.xml | Unknown APPLICATION-ID Provided | Negative | ||
SAMPLE_DTX_ACT_003.03.xml | One upload containing an approve and a correct assessment | Positive | ||
SAMPLE_DTX_ACT_003.04.xml | Negative assessment with reason: Duplicate | Negative | ||
Download of Basic UDI-DI, UDI-DI and device data | CA, EO, NB | SAMPLE_DTX_UDI_004.01.xml | Request Download Device (BUDI and UDI-DI) information using a combination of the following criteria: Basic UDIDI Code, UDIDI code, MF actor code, AR actor code | Positive |
SAMPLE_DTX_UDI_004.06.xml | Request Download Device (BUDI and UDI-DI) information using a combination of the following criteria: Basic UDIDI Code, UDIDI code, MF actor code, AR actor code Criteria: Manufacturer (State is automatic Registered), Country | Positive | ||
Upload Basic UDI-DI and UDI-DI information | EO | SAMPLE_DTX_UDI_001.01.xml | Register New MDR Device BUDI and Device (UDI-DI) information Class I Device (Special Device Type (Orthopedic), Substances, Direct Marking DI, Storage and Handling Conditions, Critical Warnings, Market Information, Clinical Sizes, Product Designer SRN) | Positive |
SAMPLE_DTX_UDI_001.02.xml | Register New MDR Device BUDI and 2 or more UDI-DI. (Special Device Type (Software), Clinical Investigations- EU and NonEU, Substances, Direct Marking DI, Storage and Handling Conditions, Critical Warnings, Market Information, Clinical Sizes, Product Designer SRN) | Positive | ||
SAMPLE_DTX_UDI_001.03.xml | Register New MDR Device BUDI and UDI-DI for a Risk Class III device to validate BUDI and UDI-DI will be stored in EUDAMED in “Submitted” status Class III (DeviceCertificateLinks, UnitofUseDI, Substances, Direct marking DI, Storage and Handling Conditions, Critical Warnings, Market Information, Clinical Sizes, Product Designer SRN) | Positive | ||
SAMPLE_DTX_UDI_001.04.xml | Register New MDR Device BUDI and UDI-DI for a Risk Class II A containing false data (e.g. containing IIb implantable exceptions – sutures) (IIb Implantable exception, Clinical Investigations- EU and NonEU, DeviceCertificateLinks, Substances, Storage and Handling Conditions, Critical Warnings, Market Information, Clinical Sizes, Product Designer SRN) | Negative | ||
SAMPLE_DTX_UDI_001.05.xml | Register New MDR Device BUDI and UDI-DI for a Risk Class II B containing certificate data and implantable and having IIb implantable exceptions – false Class IIB (IIB Implantable exceptions- false, DeviceCertificateLinks, Direct marking DI, Substances, Direct marking DI, Storage and Handling Conditions, Critical Warnings, Market Information, Clinical Sizes, Product | Positive | ||
SAMPLE_DTX_UDI_001.12.xml | Register New MDR Device BUDI and UDI-DI with multiple brand/trade names; ensure the “primary” attribute | Positive | ||
SAMPLE_DTX_UDI_001.13.xml | Register New MDR Device BUDI and UDI-DI with multiple packaging hierarchies (1st, 2nd, 3rd) and different packaging items on each level | Positive | ||
SAMPLE_DTX_UDI_002.01.xml | Register New IVDR Device BUDI and UDI-DI information Risk Class A (Storage and Handling Conditions, Critical Warnings, Market Information, Product Designer Organisation) | Positive | ||
SAMPLE_DTX_UDI_002.03.xml | Register New IVDR Device BUDI and UDI-DI for a Risk Class C device to see how the BUDI and UDI-DI will start in “Submitted” status and then transition to “Registered” status upon NB linking Risk Class C (DeviceCertificateLinks, Storage and Handling Conditions, Critical Warnings, Market Information, Product Designer Organisation) | Positive | ||
SAMPLE_DTX_UDI_003.01.xml | Register New System or Procedure Pack with only one Basic UDI | Positive | ||
SAMPLE_DTX_UDI_005.01.xml | Upload Legacy Device – Class I MDD Legacy Device | Positive | ||
SAMPLE_DTX_UDI_005.02.xml | Upload Legacy Device – AIMDD Legacy Device | Positive | ||
SAMPLE_DTX_UDI_005.03.xml | Upload Legacy Device – IVD_ANNEX_II_LIST_A Risk Class | Positive | ||
Upload a new UDI under an existing Basic UDI-DI | EO | SAMPLE_DTX_UDI_008.02.xml | Register multiple New Device UDI-DI (MDR/IVDR) information related to an already existing (MDR/IVDR) Device B-UDI | Positive |
Update Basic UDI-DI | EO | SAMPLE_DTX_UDI_009.01.xml | Update an existing MDR/IVDR Device BUDI | Positive |
SAMPLE_DTX_UDI_009.01.xml | Update an existing MDD Device BUDI | Positive | ||
Update UDI-DI | EO | SAMPLE_DTX_UDI_010.01.xml | Update an existing MDR/IVDR Device UDI-DI | Positive |
SAMPLE_DTX_UDI_010.02.xml | Update an existing MDD Device UDI-DI | Positive | ||
SAMPLE_DTX_UDI_010.03.xml | Update the first EU country where the device has been put on the market | Positive | ||
SAMPLE_DTX_UDI_010.04.xml | Set the first EU country where the device has been placed on the market for a device that was not on the EU market at the time of its registration in EUDAMED | Positive | ||
Update product original manufacturer | EO | SAMPLE_DTX_UDI_015.01.xml | Update information about the product original manufacturer registered as an organisation during the initial device registration | Positive |
SAMPLE_DTX_UDI_015.02.xml | Update information about the product original manufacturer with an Actor ID/SRN of a manufacturer registered in EUDAMED | Positive | ||
Update of Market Information | EO | SAMPLE_DTX_UDI_007.01.xml | Submit a list of market info for a specific UDI-DI | Positive |
SAMPLE_DTX_UDI_007.02.xml | Submit a list of market info for a specific list of UDI-Dis | Positive | ||
SAMPLE_DTX_UDI_007.03.xml | Submit a list of market info for a non-existing UDI-DI | Negative | ||
Update of Container Package Information | EO | SAMPLE_DTX_UDI_012.01.xml | Submit a list of container packages to a registered UDI | Positive |
SAMPLE_DTX_UDI_012.02.xml | Update the status of a container package | Positive | ||
Download issued certificate (last current version) | CA, NB | SAMPLE_DTX_CRF_02.01.xml | Downloading explicitly a known certificate by its certificate number | Positive |
SAMPLE_DTX_CRF_02.02.xml | Downloading certificates that reference a specific manufacturer by specifying its SRN | Positive | ||
SAMPLE_DTX_CRF_02.03.xml | Downloading certificates issued by other Notified Body than the Notified Body requestor | Negative | ||
Download refused certificate | CA, NB | SAMPLE_DTX_CRF_03.01.xml | Download refused certificates by its number | Positive |
SAMPLE_DTX_CRF_03.02.xml | Download refused certificates by type | Positive | ||
Download SSCP | NB | SAMPLE_DTX_UDI_009.01.xml | Download SS(C)P by Basic UDI-DI | Positive |
SAMPLE_DTX_UDI_009.02.xml | Download SS(C)P by certificate ID | Positive | ||
Download SSCP | CA, EO | SAMPLE_DTX_UDI_011.01.xml | Download SS(C)P by Basic UDI-D | Positive |
SAMPLE_DTX_UDI_011.02.xml | Download SS(C)P by certificate number / revision number | Positive | ||