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EUDAMED (European Union Medical Devices Database) uses the CEF eDelivery four-corner AS4 profile for exchanging medical device data between national competent authorities and the European Commission.

Maven Artifact

phase4-eudamed-client

Underlying Profile

CEF four-corner

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Maven dependency

<dependency>
  <groupId>com.helger.phase4</groupId>
  <artifactId>phase4-eudamed-client</artifactId>
  <version>4.4.1-SNAPSHOT</version>
</dependency>

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Overview

EUDAMED does not define its own profile module; instead it uses the CEF four-corner profile (phase4-profile-cef) and adds EUDAMED-specific HTTP client configuration. The sender builder class Phase4EudamedSender sets the profile ID to AS4CEFProfileRegistarSPI.AS4_PROFILE_ID_FOUR_CORNER automatically.

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HTTP client settings

Phase4EudamedHttpClientSettings provides EUDAMED-appropriate defaults:
SettingValue
TLS versionTLS 1.2
Connection request timeout1 second
Connect timeout5 seconds
Response timeout100 seconds
User-Agentphase4/{version} https://github.com/phax/phase4
import com.helger.phase4.eudamed.Phase4EudamedHttpClientSettings;

// Note: constructor throws GeneralSecurityException
Phase4EudamedHttpClientSettings httpSettings = new Phase4EudamedHttpClientSettings();
Phase4EudamedHttpClientSettings trusts all TLS server certificates. In production deployments, you should configure a proper TrustManager with EUDAMED’s specific CA certificates.

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Security requirements

Being based on the CEF profile, EUDAMED uses the same security settings:
SettingRequired value
Signature algorithmRSA_SHA_256
Signature hash functionSHA-256
Encryption algorithmAES-128-GCM
WSS version1.1.1
PModeAuthorizefalse
Receipt reply patternResponse
Non-repudiationtrue

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Message structure

EUDAMED follows the CEF four-corner model:
  • originalSender message property is required
  • finalRecipient message property is required
  • Agreement ID: urn:as4:agreement (inherited from CEF)
  • PartyInfo must contain at most one PartyID per side

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Sender builder

The Phase4EudamedSender class provides a fluent builder for constructing EUDAMED outbound messages: 
import com.helger.phase4.eudamed.Phase4EudamedSender;

Phase4EudamedSender.builder()
    .fromPartyID("your-from-party-id")
    .toPartyID("target-party-id")
    .payload(myPayload)
    .httpClientSettings(new Phase4EudamedHttpClientSettings())
    .sendMessageAndCheckForReceipt();
See the Phase4EudamedSender Javadoc for the full list of builder methods and required parameters.

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