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AS4
Introducing Aayu AS4 Server for Seamless EUDAMED Integration
Meet EUDAMED compliance with AS4 EDI Protocol. Enjoy secure messaging, automated retries, non-repudiation and easy setup via Aayu MFT Gateway.
Adeesha Jayasinghe
Published: 19 Dec 2025
At Aayu Technologies, we revolutionized B2B communication with the Aayu MFT Gateway and our robust AS2 and EDI products. Now, we are taking the next step in our journey. We are proud to announce our dedicated AS4 software, specifically engineered to help organizations connect effortlessly with EUDAMED (European Database on Medical Devices)
The Challenge: Navigating EUDAMED’s Mandates
For manufacturers and notified bodies in the medical device sector, compliance isn’t optional. EUDAMED uses AS4 as its mandatory communication protocol for machine-to-machine (M2M) integration. To exchange vital regulatory information such as device registrations, vigilance reports, and UDI data – you need a secure, reliable AS4 EDI connection.
However, implementing AS4 connectivity is complex. It builds on SOAP and WSS (Web Services Security) standards and requires strict adherence to security aspects like authentication, message integrity, and payload encryption.
The Solution: AS4 Made Simple
Our new AS4 solution removes the technical complexity of compliance. Built directly into the Aayu MFT Gateway, it offers the same ease of use you expect from our AS2 services, with the advanced protocol capabilities demanded by EUDAMED.
Key Benefits of Aayu AS4 Solution:
- Enterprise-Grade Security: We handle the heavy lifting of verifying sender identity, protecting message integrity, and ensuring confidentiality.
- Standardized Non-Repudiation: The system automatically manages signed receipts to prove message reception, ensuring you always have a verifiable audit trail.
- Message Pulling: Ensures receivers behind firewalls can retrieve queued messages securely.
- Error Handling and Retries: Our system visualizes the error receipts with standard AS4 error codes, and applies standard retry mechanisms for retryable error messages.
How It Works
Once you finish preparing your regulatory documents, the Aayu MFT Gateway manages the secure submission process and handles all acknowledgments from EUDAMED via the AS4 protocol. Below are the essential steps to submit your content using our solution:
Station and Partner Setup
If you have used our Aayu MFT Gateway AS2 service, you already know how to use our AS4 solution.
Certificate Exchange: Before you begin, the certificates used to validate signatures must be pre-configured and exchanged by communicating with the EUDAMED support team. Station Setup: Create a Station in the Aayu MFT Gateway, adding the specific AS4 sender “Party ID Value” and “Party ID Type” assigned to you by EUDAMED.
Partner Configuration: Similarly, set up EUDAMED as a partner using their provided Endpoint URL and Receiver Party ID details.
Submitting Messages to EUDAMED
The Aayu MFT Gateway message submission view is an easy and convenient way to submit to EUDAMED with a few clicks.
AS4 relies on “PMode” (Processing Mode) agreements. From the interface, you can easily configure the following PMode attributes which define the business rules for your specific message.
Agreement: Defines the technical and legal rules of the message. Service: Identifies the specific EUDAMED module (e.g., UDI, ACT, or CRF). Action: Describes the operation, such as “submitMessage”.
Our AS4 solution ensures your payloads meet EUDAMED’s profile rules. Simply upload your mandatory regulatory XML document (following schema version 3.0.16; view samples here) and if you have any other supporting documents, just combine them into a single ZIP file and attach alongside the primary file.
Reliability You Can Trust
We understand that message delivery failures in a regulatory environment are critical.
Automated Retries: The Aayu MFT Gateway strictly follows EUDAMED’s retry rules. Full Visibility: You can track the status of every message in real-time. Indicators show encryption, signature and compression status, while the “Receipt Status” confirms successful delivery.
Error Handling: If an error occurs, you receive standard, machine-readable AS4 error receipts with descriptive log streams to help you quickly diagnose and fix the issue.
Ready to Connect to EUDAMED?
Don’t let technical protocols slow down your compliance. Experience the reliability of Aayu MFT Gateway adapted for the future of European medical data exchange. Contact us to be notified as soon as our AS4 solution goes live.
If you’re interested in our AS4 solutions contact us
Adeesha is a Software Engineer at Aayu Technologies with around one year of experience, specializing in full-stack development. Driven by a curiosity for the “how” and “why,” he is passionate about research, exploring innovative ideas, and tackling complex problem-solving challenges. When he isn’t building software, Adeesha enjoys unwinding with a good book or watching movies.
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