EUDAMED M2M Connection

Modules, pathways, implementation – your path to EUDAMED compliance

What applies from 28 May 2026 and why the connection is now becoming a key issue

EUDAMED is the European Commission’s database for medical devices.

From 28 May 2026, the use of the first four of a total of six EUDAMED modules will be mandatory. This means that, for the first time, manufacturers, authorised representatives and notified bodies are legally obliged to maintain their regulatory data in EUDAMED accurately and on an ongoing basis.

In practice, this means that one-off, manual entries are no longer sufficient. Anyone who needs to submit large volumes of data on a regular basis – for example, due to extensive product portfolios or frequent changes – requires a robust, repeatable process. The European Commission has provided for three submission methods for this purpose. Which method is most suitable depends heavily on the volume of data and your organisation’s IT infrastructure. This is precisely where the machine-to-machine connection comes into play.

Contact us

6 EUDAMED Modules

4 mandatory from 28 May 2026

3 methods of data transmission

Key deadlines at a glance

28 November 2026 – The requirement also applies to existing products.

28 May 2027 – Existing certificates must be recorded by Notified Bodies.

The three data transmission methods

EUDAMED offers three methods of data transmission. They differ primarily in their level of automation and scalability. We can support you whichever method you choose. For long-term compliance and larger product portfolios, we consider the M2M connection to be the best option.

Webportal (UI)

Manual entry, record by record. Suitable for very few products and infrequent changes – but quickly becomes time-consuming as the portfolio grows.

XML Bulk Upload

Semi-automatic: data is uploaded as an XML file in accordance with the EUDAMED schema. Large portfolios must be split up; validation takes place at a later stage.

M2M interface

Fully automated data exchange between your ERP/QMS and EUDAMED – scalable, validated and auditable. The most viable option for many manufacturers.

Machine-to-Machine – how the connection works

With the M2M connection, your existing system communicates directly with EUDAMED. Data flows from SAP, QMS or PLM via a secure interface, is validated by the system prior to upload and is fully logged. adesso builds, validates and operates this connection in collaboration with you.

Advantages at a glance

  • Single Source of Truth: Direct transfer from SAP/QMS. No media break, no duplication.
  • Pre-validation before upload: In-system validation against the EUDAMED schema (XSD) prior to transmission – this largely prevents rejected submissions.
  • Scalable: 100 or 50,000 products – the same process. Bulk transfer in a single run instead of manual entry.
  • Complete audit trail: Every transaction is logged by the system – recorded in accordance with regulations and traceable.
  • Direct system integration: Interface with your internal systems – no more manual data extraction.
  • Automatic synchronisation: Status changes are transmitted promptly and automatically – in compliance with MDR/IVDR reporting obligations.

Data flow

Your ERP / QMS / PLM (e.g. SAP, Windchill, Veeva) → M2M interface (mapping, XSD pre-validation) → EUDAMED (validated & auditable)

Where the time savings come from

The benefit does not stem from a single feature, but from the fact that recurring manual work is handled by the system.

  • No manual synchronisation: Data flows directly from ERP/QMS – no copy-pasting between the portal and internal systems, no duplicate data entry.
  • Automatic status checking: Certificate status, regulatory decisions or feedback are automatically recognised, rather than having to look them up in the portal.
  • Automatic linking: Relationships such as UDI-DI to certificate or operator to product are matched by the system rather than assigned manually.
  • Pre-upload validation: Errors are detected before submission – this reduces the number of rejected submissions and the associated rework.
  • Batch processing: Many data records are processed in a single run – the workload no longer increases linearly with the portfolio.
  • Deadlines without time pressure: Notifications are submitted automatically and in a repeatable manner – statutory deadlines are not jeopardised by manual steps.

Who is affected by EUDAMED obligations?

Use of the modules is required by law. Obligations vary depending on the role.

Medical device manufacturers (manufacturing companies)

  • ACT – SRN obligation: application & master data
  • UDI – Product registration of all devices
  • CRF – Monitor certificate status
  • MSU – Market surveillance measures
  • VIG & CIPS – Vigilance and clinical (planned)

Notified Body (NB)

  • ACT – Registration as an NB with SRN
  • CRF – Batch upload of CE certificates
  • ACT – Linking manufacturer ↔ SRN
  • UDI – Certificate matching (read-only)

Importers / Authorised Representatives (AR/IMP, EU representatives)

  • ACT – Registration as AR/IMP with SRN
  • ACT – Linking to the manufacturer
  • UDI – Verification of product data
  • CRF – View certificate status

An overview of the six modules

Economic Operator Registration (ACT)

Relevant for: Manufacturers, importers, authorised representatives

Status: Active

Management of all economic operators and issuance of Single Registration Numbers (SRN) – the master data foundation upon which all other modules are built.

Product Registration (UDI)

Relevant for: Manufacturers

Status: Active

The central module: Basic UDI-DI, UDI-DI and Legacy Devices. For most manufacturers, this is the most comprehensive module – with strict data mapping and versioning logic.

Certificates (CRF)

Relevant for: Manufacturers (read-only) and Notified Bodies (write access)

Status: Active

CE and QMS certificates as well as SSCP. Manufacturers monitor the status; Notified Bodies upload certificates and link them to UDI-DIs.

Market Surveillance (MSU)

Relevant for: Manufacturers and competent authorities (CAs)

Status: Active

Exchange of information on market surveillance measures (MUCA), inspections and regulatory decisions – relevant for compliance monitoring and audit preparation.

Vigilance (VIG)

Relevant for: Manufacturers

Status: Planned

Reporting of incidents and corrective actions (MIR, FSCA, FSN, PSUR) with statutory deadlines – requires close integration with the complaint management system.

Clinical trials (CIPS)

Relevant for: Manufacturers and sponsors

Status: Planned

Registration of clinical trials and performance studies in accordance with MDR/IVDR, including linking of investigational devices via UDI-DIs.

Do you also market your products in Switzerland?

In that case, MDR certification alone is not sufficient: whilst the CE mark is recognised, you will also need a Swiss authorised representative (CH-REP) and registration with Swissdamed. A shared M2M pipeline can serve both databases.

Read more

We support you with the M2M connection

From the initial classification through to the integration of your systems and on to validated, auditable transmission to EUDAMED – we guide you every step of the way. Start with a brief, no-obligation discussion.