swissdamed Updates: EMDN-Codes and Legacy Devices

swissdamed Updates:
EMDN Codes and Legacy Devices

Swissmedic has published two key swissdamed releases: With version 2.2.1, swissdamed supports the current EUDAMED schema (XSD 3.0.25 / platform 2.22.0), including updated EMDN codes. Shortly thereafter, version 2.3.0 enables the upload of Legacy Devices for the first time and specifies which identifiers must be used depending on the initial situation.
Source: swissmedic.ch

1.) 03.02.2026 – Version 2.2.1: XSD 3.0.25 and updated EMDN codes

With release 2.2.1, swissdamed supports XSD version 3.0.25, which corresponds to the current EUDAMED version 2.22.0 – including the updated EMDN codes.

Practical implications:

XML generators and validations should be tested against XSD 3.0.25 (schema version, mandatory fields, enumerations).
EMDN mappings should be reviewed and updated to avoid errors in code validations.
For integrations (Bulk/M2M): requests and validation chains must be aligned with the new XSD version.

2.) 05.02.2026 – Version 2.3.0: Legacy Devices upload in the UDI Devices Module

With release 2.3.0, Legacy Devices – i.e., devices that were placed on the market under the old legislation (Art. 101 MedDO / Art. 82 IvDO) – can be uploaded and registered in swissdamed within the UDI Devices Module.

The identification rules depend on whether a UDI-DI already exists for the Legacy Device or not.

A) If a UDI-DI already exists

The Legacy Device retains the existing UDI-DI. In addition, an EUDAMED DI is used, which is derived directly from the UDI-DI:
EUDAMED DI = “B-” + (UDI-DI value)

An EUDAMED ID is not relevant in this scenario.

B) If no UDI-DI exists

The manufacturer assigns an EUDAMED DI according to the following fixed format:
EUDAMED DI = “B-” + DD(1–21) + X1 + X2

DD is a manufacturer-defined device identification component (max. 21 characters) and X1/X2 are calculated check digits.

In addition, an EUDAMED ID is assigned, which is created from the EUDAMED DI:
EUDAMED ID = “D-” + (EUDAMED DI)

The calculation of the check digits (X1/X2) is described in the official EUDAMED documentation and should be automated in the tooling.

Interested in integrating swissdamed into your UDI processes?
As the Europe-IT team, we are ready to seamlessly integrate swissdamed requirements into our proven UDI solutions – as soon as the final technical specifications from Swissmedic are available.

Learn more about our solutions: