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 NRDs (Old/Custom-made devices) |
CA, EO |
SAMPLE_DTX_UDI_016.01.xml |
Request Download of NRDs (Old/Custom-made) information using a combination of the following criteria: NRD code, 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 NRDs (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 |