Second Set of Frequently Asked Questions about EUDAMED: Scope

By Tom Ingless and Evangeline Loh

What is one registration in the UDI/DEV module?

Regulation devices (MDR and IVDR) are initially registered at the Basic UDI-DI level. This is the main key in the database and relevant technical documentation and is used to connect devices with the same intended purpose, risk class and essential design and manufacturing characteristics. Once this has been added to the UDI/DEV module, each UDI-DI (a numeric identifier specific to a model, variation or version of a device) that is associated with the Basic UDI-DI needs to be registered. An infographic outlining the concept of regulation device registrations has been provided by the EU Commission.

Legacy devices (MDD, IVDD and AIMDD) are initially registered at the EUDAMED DI level and then the EUDAMED ID is added. These are EUDAMED-generated and -specific codes that are functionally equivalent to the Basic UDI-DI and UDI-DI, respectively. Legacy devices are expected to be linked to the same regulation device if and when they transition to the MDR or IVDR, either manually or automatically. Further information is available from the EU Commission.

What is “placing on the market”?

“Placing on the market” refers to the definition in Article 2 (28) of the MDR, i.e., the first time that a device (other than an investigational device) is supplied on the EU market for distribution, consumption or use in the course of a commercial activity, whether in return for payment or free of charge.

If devices from the same UDI-DI have been placed on the market before May 28, 2026, the UDI/DEV registration is not required until November 27, 2026. Thus, if the “first (sales) unit” were placed on the market before the end of May 2026, the subsequent “additional (sales) units belonging to the same UDI-DI” can continue to be placed until November 26, 2026, without a UDI/DEV registration. 

Do these registration deadlines (assume November 27, 2026) apply to legacy devices?

Assume that the legacy devices have been placed on the market before May 28, 2026. Yes, if the legacy devices continue to be placed on the market after November 27, 2026, the legacy devices need to be registered in the UDI/DEV module, otherwise if they were taken off the market before this date, then they do not need to be registered.

The caveat to this is the vigilance (VGL) module. If a legacy device which stopped being sold before the mandatory registration deadline (November 27, 2026) or an “old” device (which was taken off the market before MDR and IVDR dates of application) is still in use in the EU market after the mandatory use date of the VGL module (date still TBD at present) AND is the subject or a serious incident or field safety corrective action (FSCA), it must be registered using a simplified process to enable appropriate reporting within EUDAMED.

Now that EUDAMED UDI/DEV is mandatory, are Member State Notifications still required?

While the entire purpose of the regulations and EUDAMED is to eliminate member state notifications, we have heard some differences in Competent Authority interpretation. This is a topic we’re actively monitoring and will further discuss during the MDCG Medical Device Coordination Group meeting in Brussels, June 9, 2026. We will continue to report on this.

When the Clinical Investigations and Performance Evaluation (CI/PS) Module becomes mandatory, will these need to include all CI and PS globally?

No, only CI and PS performed in the EU need to be reported in the CI/PS Module of EUDAMED.

Concluding remarks

This is part 2 of a series of regulatory updates on FAQs about EUDAMED based on questions received during our recent EUDAMED webinar. Part 1 discussed the timelines.