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 (Basic UDI-DI and UDI-DI) information using a combination of the following criteria: Basic UDI-DI Code, UDI-DI code, MF actor code, AR actor code | Positive |
SAMPLE_DTX_UDI_004.06.xml | Request Download Device (Basic UDI-DI and UDI-DI) information using a combination of the following criteria: Basic UDI-DI Code, UDI-DI code, MF actor code, AR actor code Criteria: Manufacturer (State is automatic Registered), Country | Positive | ||
Download Old/Custom-made devices | CA, EO | SAMPLE_DTX_UDI_016.01.xml | Request Download Old/Custom-made information using a combination of the following criteria: Device Identifier, UDI-DI code, Basic UDI-DI code, Applicable legislations, Risk class, Device status, Device is custom-made, Version State | Positive |
SAMPLE_DTX_UDI_016.02.xml | Request Download of Old/Custom-made devices information without Version State | Negative | ||
Upload Basic UDI-DI and (Master) UDI-DI information | EO | SAMPLE_DTX_UDI_001.01.xml | Register New MDR Device Basic UDI-DI 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 Basic UDI-DI 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 Basic UDI-DI and UDI-DI for a Risk Class III device to validate Basic UDI-DI 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 Basic UDI-DI 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 Basic UDI-DI 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 Basic UDI-DI and UDI-DI with multiple brand/trade names; ensure the “primary” attribute | Positive | ||
SAMPLE_DTX_UDI_001.13.xml | Register New MDR Device Basic UDI-DI 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 Basic UDI-DI 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 Basic UDI-DI and UDI-DI for a Risk Class C device to see how the Basic UDI-DI 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-DI | 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 (Master) 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 Basic UDI-DI | Positive |
Update Basic UDI-DI | EO | SAMPLE_DTX_UDI_009.01.xml | Update an existing MDR/IVDR Device Basic UDI-DI | Positive |
SAMPLE_DTX_UDI_009.02.xml | Update an existing MDD Device Basic UDI-DI | Positive | ||
Update (Master) 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 SS(C)P | 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 SS(C)P | CA, EO | SAMPLE_DTX_UDI_011.01.xml | Download SS(C)P by Basic UDI-DI | Positive |
SAMPLE_DTX_UDI_011.02.xml | Download SS(C)P by certificate number / revision number | Positive | ||
Download CECP | CA | SAMPLE_DTX_CRF_04.01.xml | Download all CECP records within a date interval | Positive |
SAMPLE_DTX_CRF_04.02.xml | Download a CECP record by its Application ID and within a date interval | Positive | ||
SAMPLE_DTX_CRF_04.03.xml | Download all CECP records by the conformity assessment type and within a date interval | Positive | ||
SAMPLE_DTX_CRF_04.04.xml | Download all CECP records by the device type (CLASS_III or CLASS_IIb) and within a date interval | Positive | ||
SAMPLE_DTX_CRF_04.05.xml | Download a CECP record by the device identification: i) Basic UDI-DI ii) device by Name and iii) device by Model and within a date interval | Positive | ||
SAMPLE_DTX_CRF_04.06.xml | Download all CECP records for a given Economic Operator SRN (MF/AR) and within a date interval | Positive | ||
SAMPLE_DTX_CRF_04.07.xml | Download all CECP records in a certain status and within a date interval | Positive | ||
Final inspection report download | CA, NB | SAMPLE_DTX_MSU_001.01.01.xml | Download all final inspection reports initiated by Belgian competent authority | Positive |
Annual summary report download | CA | SAMPLE_DTX_MSU_001.02.01.xml | Download all annual summary reports initiated by Belgian competent authority | Positive |
4 years summary report download | CA | SAMPLE_DTX_MSU_001.03.01.xml | Download all 4 years summary reports initiated by Belgian competent authority | Positive |
Download Vigilance Report | EO, CA, NB | SAMPLE_DTX_VIG_001.01.xml | Download a specific MIR report | Positive |
SAMPLE_DTX_VIG_001.02.xml | Download a range of FSN reports based on a partial "like" value | Positive | ||
SAMPLE_DTX_VIG_001.03.xml | Download all MIR reports using "dashboardReportType" parameter | Positive | ||
SAMPLE_DTX_VIG_001.04.xml | Download all FSCA reports created after a specific Date using "dashboardReportType" parameter | Positive | ||
Create MIR report | EO | SAMPLE_DTX_VIG_002.01.xml | Create an MIR report with the status "INITIAL" | Positive |
Update MIR report | EO | SAMPLE_DTX_VIG_002.02.xml | Update an MIR report to the status "FOLLOW UP" | Positive |
Create FSCA report | EO | SAMPLE_DTX_VIG_003.01.xml | Create an FSCA report with the status "INITIAL" | Positive |
Update FSCA report | EO | SAMPLE_DTX_VIG_003.02.xml | Update an FSCA report to the status "FOLLOW UP" | Positive |
Create FSN report | EO | SAMPLE_DTX_VIG_004.01.xml | Create an FSN with the status "FINAL" | Positive |
Update FSN report | EO | SAMPLE_DTX_VIG_004.02.xml | Update an FSN to the status "FINAL" | Positive |
Create MTR report | EO | SAMPLE_DTX_VIG_005.01.xml | Create an MTR report with the status "INITIAL" | Positive |
Update MTR report | EO | SAMPLE_DTX_VIG_005.02.xml | Update an MTR report to the status "FOLLOW UP" | Positive |
Create PSUR report | EO | SAMPLE_DTX_VIG_006.01.xml | Create a PSUR report | Positive |
Update PSUR report | EO | SAMPLE_DTX_VIG_006.02.xml | Update a PSUR report | Positive |
Create NCAR report | CA | SAMPLE_DTX_VIG_007.01.xml | Create an NCAR report of type "GENERAL" | Positive |
Update NCAR report | CA | SAMPLE_DTX_VIG_007.02.xml | Update an NCAR report of type "GENERAL" | Positive |