The European Commission prepares stakeholders for the mandatory use of EUDAMED

Tom Ingless and Annette van Raamsdonk 

Last year, we shared an update on the gradual rollout of the European Database on Medical Devices (EUDAMED). While deadlines have shifted again, the European Commission (EC) is preparing stakeholders for registering devices in the Unique Device Identification (UDI)/Device Module.

On Sept. 30 and Oct. 1, Emergo by UL participated in the EC’s EUDAMED onboarding training for the UDI/Device module. 

Current timeline

The timeline for EUDAMED’s implementation has shifted, with the first notice on the readiness of the Actor, UDI/Device. Notified Bodies (NB) and Certificates, and Market Surveillance modules are expected to be published in the Official Journal of the European Union (OJEU) in mid-November 2025. 

Once the notice in the OJEU is published, there follows a 6-month transitional timeline to allow manufacturers to prepare. Depending on their status, devices have different registration requirements, as follows:

• Each NEW device (compliant with the Medical Device Regulation (MDR) or In Vitro Diagnostic Regulation (IVDR) placed onto the market on or after the publication date of the notice in the OJEU must be registered in EUDAMED within 6 months, i.e., likely by mid-May 2026. (NB: this means a new MDR device, not a device belonging to a generic device group which is already on the market).
• Legacy devices, which are still placed onto the market with appropriate transition extensions and Regulation devices, which were placed onto the market prior to the publication of the notice in the OJEU, must be registered within 12 months, i.e., likely by mid-November 2026.

• Legacy devices (Medical Devices Directive (MDD) / Active Implantable Medical Devices Directive (AIMDD) / In Vitro Diagnostic Medical Devices Directive (IVDD) that were no longer placed on the market before the publication date of the notice in the OJEU but are still circulating in the distribution chain do not need to be registered unless a vigilance issue occurs during mandatory use of the Post-Market Surveillance (PMS) Vigilance Module. The PMS Vigilance Module is not expected to become mandatory before Q2 2027.

   

Summary of the EUDAMED onboarding training

The EC provided stakeholders with onboarding training so that they could train their members. Emergo by UL, along with other European Authorized Representatives, attended the two-day training and is preparing a webinar on EUDAMED registrations. We will touch on some of the topics discussed.

1. Types of device identifiers and their hierarchy relationships

   EUDAMED uses several types of device identifiers to manage and track devices:

   • Basic Unique Device Identification–Device Identifier (UDI-DI): The core identifier grouping devices with the same intended purpose and design. It acts as an umbrella for multiple UDI-DIs and is mandatory for regulated devices.
   • UDI-DI: A unique identifier for a specific device model. It appears on device labeling and is used for traceability.
   • Package UDI-DI: Identifies packaging configurations and quantities at each package level.
   • Master UDI-DI: This is used for special device types (e.g., contact lenses) to simplify registration. It replaces multiple UDI-DIs with a single identifier for grouped products.
   • The identifier hierarchy in EUDAMED is structured as follows:
     • One Basic UDI-DI can be linked to multiple UDI-DIs
     • Each UDI-DI can have associated Package UDI-DIs
     • Registration of a Basic UDI-DI must include at least one UDI-DI
     • Additional UDI-DIs can be added later through device management

2. Device registrations for legacy devices

   Legacy devices refer to medical devices, in vitro diagnostic devices, or active implantable devices that were placed on the EU market under previous directives (MDD, AIMDD, IVDD) and continue to be marketed during the transition to MDR/IVDR. These devices are not yet certified under the new regulations but remain available under transitional provisions unless significant changes in design or intended purpose occur. These devices do not require registration in EUDAMED, unless the PMS Vigilance module is live and a vigilance event occurs. 

3. The registration of “Regulation Devices.” Regulation devices refer to medical devices and in vitro diagnostic medical devices that are placed on the EU market under the MDR or IVDR.

   What data do you need to keep ready when registering these devices? 

   •    Basic UDI-DI and UDI-DI codes
   •    European Medical Device Nomenclature (EMDN) codes and trade names
   •    Device characteristics (e.g., size, sterilization, warnings)
   •    Market distribution details
   •    Clinical investigation information (if applicable)
   •    Substances (e.g., carcinogenic, mutagenic or reprotoxic (CMR), endocrine disruptors) if present

4. Linking legacy devices and regulation devices
5. Bulk Upload Functionality
6. Managing versions

Concluding remarks

With this two-day training, the EC prepares stakeholders for the mandatory use of EUDAMED. While the targeted evaluation of the Regulations is ongoing, the implementation and rollout of EUDAMED are as well. Emergo by UL is preparing an EUDAMED webinar to help manufacturers, system and procedure pack producers, and importers prepare so they know what to expect when the UDI/Device Module of EUDAMED becomes mandatory. 

Emergo by UL takes part in several European Commission Medical Device Coordination Groups (MDCG) and will keep you updated on any developments. For further information, make sure you are signed up for our newsletter.