Accelerating EUDAMED Rollout: Key Dates and Requirements for Medical Device Manufacturers

Accelerating EUDAMED Rollout: Key Dates and Requirements for Medical Device Manufacturers

The rollout of EUDAMED (European Database on Medical Devices) is entering a critical phase. With the publication of Regulation (EU) 2024/1860, deadlines are now clearly defined for medical device manufacturers and other economic operators. This progressive yet firm timeline will structure the implementation of this essential European database, crucial for market transparency and medical device safety.

Gradual EUDAMED Rollout

Unlike the original MDR and IVDR regulations, which required all modules to be operational before EUDAMED became mandatory, Regulation (EU) 2024/1860 introduces a more pragmatic approach: a progressive, module-by-module rollout.

Modules Available by 2025

Four EUDAMED modules are currently operational and available for voluntary use:

●      Actor Registration Module

●      Medical Device (UDI) Registration Module

●      Notified Bodies and Certificates Module

●      Market Surveillance Module

Upcoming Modules:

●      Vigilance and Post-Market Surveillance Module

●      Clinical Investigations and Performance Studies Module (under development)

Economic Operator Registration

Registration in the Actor Module will become mandatory starting Q1, 2026, for all relevant economic operators, including:

●      Medical device manufacturers

●      System and procedure pack producers

●      Authorized representatives

●      Importers

Medical Device Registration

Key dates for mandatory device registration:

●      From Q1, 2026: New devices placed on the market after this date must be registered immediately in EUDAMED.

●      By Q3, 2026: Devices already on the market before Q1 2026, must be registered if they are still being placed on the market.

Special Case: Legacy Devices (MDD)

Devices placed on the market under the previous MDD, AIMD, or IVDD directives and benefiting from transition periods must be registered in EUDAMED by Q3, 2026, unless the same device is already registered under MDR. 

Important: If a vigilance action concerns an unregistered legacy device, immediate registration will be required within a short timeframe.

"Old devices" and custom-made devices don't require EUDAMED registration.

Key Distinction: EUDAMED Registration vs. MDR/IVDR Transition Periods

It is crucial to differentiate between EUDAMED registration deadlines and the MDR/IVDR compliance transition periods.

Transition Periods for Medical Devices (excluding IVDs)

Transition periods for medical devices under MDD vary by risk class:

●      Until May 26, 2026: Class III and custom-made implantable devices

●      Until December 31, 2027: Class III and implantable Class IIb devices (with exceptions, e.g., sutures)

●      Until December 31, 2028: Other Class IIb, IIa, and Is/m devices (including Class I requiring a Notified Body)

Transition Periods for In Vitro Diagnostic Devices (IVDs)

IVDs benefit from extended transition periods based on their class:

●      Until December 31, 2027: for devices covered by an IVDD certificate and Class D

●      Until December 31, 2028: Class C

●      Until December 31, 2029: Class B and sterile Class A

EUDAMED Implementation Conditions and Technical Requirements

When a EUDAMED Module Becomes Mandatory

Use of a specific EUDAMED module becomes mandatory six months after its publication in the Official Journal of the European Union (OJEU), provided an audit confirms its essential functionalities are operational.

Technical Preparation and M2M Exchange: What Manufacturers Need to Know

For medical device manufacturers, automated data exchange (Machine-to-Machine, M2M) with EUDAMED will be essential and offer operational advantages. Preparation requires:

●      Setting up a compatible technical architecture

●      Validation of the UDI submission solution by regulatory and/or quality departments

●      Testing within the EUDAMED test environment

●      Securing necessary approvals for M2M communication

Practical Steps to Meet EUDAMED Deadlines

1. Priority: Registration of Economic Operators

Registering as an economic operator is the first mandatory step. Manufacturers and system/procedure pack producers must obtain their Single Registration Number (SRN) before registering devices.

2. Preparing Device Data & Alignment to EUDAMED

Given the complexity of EUDAMED’s data model, careful preparation is critical:

●      Inventory of relevant devices per market

●      Verification of UDI-DI and Basic UDI-DI compliance

●      Data collection

●      Data quality and integrity validation

3. Choosing a UDI Registration Method

Depending on device volume and update frequency, three approaches are available:

●      Manual registration: suitable for small data volumes

●      XML file upload: semi-automated, more complex. UDI limitation per XML file to 40.

●      Full machine-to-machine (M2M) integration: highly recommended for larger volumes

4. Testing and Validation

Before official deadlines:

●      Use the EUDAMED test environment (Playground)

●      Verify data compliance

●      Train staff on EUDAMED registration procedures

Avoid Bottlenecks: Plan Ahead

As the critical 2026 deadlines approach, registration bottlenecks are likely. Manufacturers who plan ahead will benefit from:

●      Smoother registration processes

●      Spread-out workload

●      Improved regulatory compliance for partners

Consequences of Non-Compliance with EUDAMED Registration

Failure to comply with EUDAMED registration obligations may result in:

●      Audit non-conformities

●      Loss of access to the EU market

●      Possible withdrawal of devices from the EU market

●      Administrative and financial penalties

●      Damage to reputation with clients and distributors

Conclusion

The EUDAMED 2025–2026 timeline represents a decisive shift in European medical device regulation. With deadlines now firmly set, manufacturers and other economic operators must fully commit to meeting these new requirements.

Far from being a simple administrative task, EUDAMED registration forms a cornerstone of Europe's new approach to transparency, traceability, and device safety. Manufacturers who anticipate and adapt effectively will not only achieve compliance— they will secure a strategic advantage in a rapidly evolving European market.

The countdown has begun—preparation must start now to meet the critical 2026 deadlines.

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