Purpose
The purpose of this topic is to help Competent Authorities, Notified Bodies, as well as all Economical Operators (Manufacturers, Authorised Representatives, Importers, and System/Procedure Pack Producers) in assessing the most cost-efficient solution for their needs to comply with the Medical Devices Regulation.
Although EUDAMED offers multiple ways of inputting/downloading data, there are several parameters to take into consideration before making a decision.
The different data input methods are:
The User Interface: this option implies manual input of data through the application.
The XML upload/download: this option is a semi-automated one, where the data can be uploaded by means of XML files. The XML data must be validated against the provided EUDAMED DTX service and entity model XSDs. The generation of the files can be automated, but the action of uploading/downloading the files remains manual.
The Data Exchange (DTX) Machine-to-Machine (M2M) system: this option allows for automatic data exchange between an external backend system and EUDAMED backend services (in bulk as well). The End User enters information in the external system, and the data is automatically transmitted to EUDAMED, in XML format following the same conditions as previously mentioned without any human intervention. However, the connection of two systems in a fully automatic way may be too costly considering many architectural, technological and operational aspects (e.g. local application readiness, interoperability, infrastructure, security, support, etc.) if the frequency and/or volume of transmission remains low.
These guidelines cover only the assessment of data related to the EUDAMED modules that are available and can be used on voluntary basis: Actors registrations, UDI/Devices, and NBs & Certificates modules.