M2M data exchange architecture

The M2M data exchange allows the automatic data exchange between a public/private organisation (external system) and EUDAMED. To achieve this, the external system must convert its data into the XML format that EUDAMED supports. Moreover, the external system must install and configure a dedicated CEF eDelivery Access Point and a secure AS4-compliant communication protocol on its premises in order to establish a secure link with EUDAMED.

The EUDAMED M2M data exchange defines a set of building blocks that should be specified and implemented to enable the information exchange between public/private organisations and EUDAMED.

Organisation Backend: Represents a dedicated information exchange gateway. It implements a specific communication protocol, service and entity data exchanged between the organisations and EUDAMED, compliant with the EUDAMED service and data model.

Access Point: The organisation’s AP will deliver the messages to the EUDAMED AP. The EUDAMED AP will acknowledge or respond to the organisation’s requests. Both must be AS4-compliant. Domibus is used on the EUDAMED side.

EUDAMED Backend: Is responsible for the data exchange message requests, including the security, access control and reliability aspects, and for constructing the messageresponses.