Quick Start
CertHub allows you to download an XML file that you can use to register your device to EUDAMED. It generally provides you with two XML files, one to register the Basic UDI and one to register all of your UDI-DIs for this Basic UDI.
Registration process
Download XMLs
If you wish to register your device to EUDAMED make sure you filled in every information needed for EUDAMED into your product in CertHub. Also make sure to verify that the regulatory properties are correct.
Head to your product and click on "Download EUDAMED Registration". CertHub will perform some validations for you and inform you if the information is incomplete or invalid for some other reasons.
Upload to EUDAMED
In EUDAMED head to Data Transfer -> Bulk Upload and Click on "New Upload".
To register your Basic UDI select the service "Upload of Legacy / Regulation Device / SPP" and upload the Basic UDI Registration XML.
If your device has more than one variant (UDI-DIs) you need to register them in a second step. Please wait until the first upload suceeded and then click on "new Upload" again. To register the UDI-DIs, select the service "Upload of UDI-DI / Master UDI-DI for existing Basic UDI" and upload the UDI-DI Registration XML.
How to enter the information in to CertHub
To generate the XML CertHub needs to know where to find the information required for EUDAMED. As most of these informations will be stored inside the Knowledge Topics CertHub uses a special attribute to find the relevant information in your product database. If you are using the templates that our team provided for you these attributes are already set correctly, only if you made substantial changes to our templates or you created your own schemes you need to set them manually.
Set the reference attribute
To set the reference attribute, head to the KT editor and add or select the form field, where the required information will be stored in. In the side bar go to "Custom Properties" and add a new entry. As key enter "certhub-key" and fill the value with the specified reference. You can find a full list of all required CertHub Keys below.
Required References
All references that CertHub uses to generate your XML are listed here. Some CertHub Keys need to be in a specific (Multi-)KT, also please make sure that you use the right form field (Text, Date, Checkbos or Number) in your KT forms.
| KT | Single / Multi | CertHub Key | Expected Form Field | Remarks |
|---|---|---|---|---|
| Global Element: Company Information | Global Element | information | Text | Set this field in the entry, where you specify what information you store in this record. (e.g. SRN, Company Name, etc.) |
| Global Element: Company Information | Global Element | details | Text | |
| Target Markets | Multi | country_code | Text | Only one Country Code (e.g. DE, AT, etc.) per record |
| Target Markets | Multi | original_placed_on_the_market | Checkbox | |
| Target Markets | Multi | start_date | Date | |
| Target Markets | Multi | end_date | Date | |
| UDI Management | Multi | udi_di | Text | Needs to be a valid UDI-DI |
| UDI Management | Multi | udi_di_issuer | Text/Select | Valid values: GS1; IFA; HIBCC; ICCBBA |
| UDI Management | Multi | base_quantity | Number | |
| UDI Management | Multi | pielements | Text/Tag List | Valid values: BATCH_NUMBER; SOFTWARE_IDENTIFICATION; EXPIRATION_DATE; MANUFACTURING_DATE If you use multiple UDI-PI Elements for a single UDI-DI, use a Tag List |
| UDI Management | Multi | new_device | Checkbox | Only for IVDR devices |
| Variants/Configurations | Multi | emdn_codes | Text | Needs to be valid EMDN Codes, if more than one applies to your product separate them by comma |
| Variants/Configurations | Multi | number_of_reuses | Number | |
| Variants/Configurations | Multi | sterile | Checkbox | |
| Variants/Configurations | Multi | sterilization | Checkbox | |
| Variants/Configurations | Multi | reference_number | Text | Falls back to serial number if missing |
| Variants/Configurations | Multi | variant_description | Text | |
| Variants/Configurations | Multi | name | Text | |
| Variants/Configurations | Multi | latex | Checkbox | Only for MDR products |
| Clinical Evaluations | Multi | clinical_investigation_reference | Text | Only required if Class IIb or III |
| Clinical Evaluations | Multi | non_euapplicable_countries | Text | Only required if Class IIb or III |
| Single | animal_tissue_cells | Checkbox | ||
| Single | human_tissue_cells | Checkbox | ||
| Single | human_medicinal_product | Checkbox | ||
| Single | administering_medicine | Checkbox | ||
| Single | device_type | Text/Select | Valid values: DEVICE; PROCEDURE_PACK; SYSTEM | |
| Single | general_description | Text | ||
| Single | companion_diagnostics | Checkbox | Only for IVDR | |
| Single | instrument | Checkbox | Only for IVDR | |
| Single | kit | Checkbox | Only for IVDR | |
| Single | microbial_substances | Checkbox | Only for IVDR | |
| Single | near_patient_testing | Checkbox | Only for IVDR | |
| Single | professional_testing | Checkbox | Only for IVDR | |
| Single | self_testing | Checkbox | Only for IVDR | |