Requirements for the different modes of data input
Brief description of the requirements for the three data input methods:
The User Interface (UI)
This option is the simplest one from a data handling/manipulation/implementation point of view. The User only needs a PC with Internet connection and a browser to connect to EUDAMED.
The XML bulk upload/download through EUDAMED UI
In addition to the requirements to connect to EUDAMED, the User will need to provide (upload) the data in XML format to EUDAMED. This will allow bulk upload of existing information by uploading the XML files through the User Interface. It is advisable to produce the XML format data in an automatic way to avoid validation errors of the data. Some implementation effort by an IT team will be required taking into consideration the complexity of the data format (XSDs) and validation rules (e.g. field sizes, tags positions, mandatory/vs. not mandatory, etc.).
Similarly, the User will only be able to bulk download the data in XML format. This format, although understandable, is not easy to be read. Software that displays this information in a more readable structure should be considered.
The Machine-to-Machine Data Exchange (M2M-DTX)
In this case, the data will be automatically transmitted between an external system and EUDAMED. To achieve this, the external system must be extended to convert its data into the XML format requested by EUDAMED DTX and implement a specific data exchange protocol.
Furthermore, to establish the connection through eDelivery, there is a need to link the external system with an Access Point. This Access Point needs to be installed on specific hardware on premises, and maintained (support, versions updates, configuration, etc.).
When EUDAMED is fully functional, in the event of a change being implemented that requires a change to the DTX (for example new functionality or a change to the validation rules for a field), there will be a period (usually 6 months') of notice and both the old and new XSD will work for that period. After that period, all systems connected to EUDAMED will need to have been updated to continue to work for data exchange. During EUDAMED development phase, i.e. before it is fully functional, any DTX changes will be communicated 4 to 6 weeks prior to a new release.
Overall, this is the most complex and costly solution, which should only be considered under the following conditions:
The Actor that needs to exchange data with EUDAMED has a database outside EUDAMED for these data.
The amount of data to be uploaded/downloaded is too important for being entered/extracted manually (would be too burdensome and too long).
There will be frequent exchanges of information with EUDAMED.
The cost of manual input outweighs the cost of automation.
The Actor has enough available and necessary resources, competence and infrastructure for implementation and maintenance.