EUDAMED Registration in Practice: SRN, UDI Data, Master UDI-DI and swissdamed

The EUDAMED Data Challenge

Processing your CE and obtaining an SRN can be challenging. While the MDR and IVDR are relatively stabilized, the addition of the UDI and SRN requirements adds to the documentation and paperwork. In draft stage an importer cant link UDI-DI, and based on device grouping UDI-DI should be updated. The challenge is more handling the data than the knowledge gap. This blog covers actor registration, UDI structure, certificates, clinical investigations, market surveillance, Master UDI-DI and how to apply through the Swiss portal.

The Six EUDAMED Modules

EUDAMED is a Europe’s database where all medical devices being sold in the continent will be tracked and managed. EUDAMED has six connected modules, as listed below.

Before You Start Working on the EUDAMED Portal

Before you start working on the EUDAMED portal, please ensure that you have:

Ensure that this structure matches the intended purpose, risk classification and certificates. This will help verify the data, confirm the market status and manage change control. Documents upload at EUDAMED does not follow a single deadline: the first four modules became mandatory on 28 May 2026, while applicable legacy and Regulation devices placed on the market before that date and continuing to be placed on the market must be registered in the UDI/Device module by 28 November 2026.

Master UDI-DI Requirements for Highly Individualised Devices

It is important to understand that different products have different requirements. The European regulations have published practical guidelines for different kinds of products. Master UDI-DI groups highly individualised devices.

Contact lenses: Commission Delegated Regulation (EU) 2023/2197, with changes in application date under regulation (EU) 2025/788.

Spectacle frames, lenses and ready to wear readers: Regulation (EU) 2025/1920.

Practical guidance: MDCG 2024-14 Rev. 1, MDCG 2025-7 and MDCG 2025-8.

EUDAMED Registration Does Not Replace swissdamed Registration

Many manufacturers make the mistake of assuming that if they have registered on EUDAMED, they can also sell their products in Switzerland. However, Switzerland has a separate portal but with same functions for medical devices and In-Vitro devices called swissdamed. It is important to register separately to continue legally selling in Switzerland.

Managing the EUDAMED Portal and Data-Cleanup Effort

Morulaa can support the complete management of your EUDAMED portal. We find that the team’s effort really depends on the cleanup of the data. Below is a practical map of the amount of time you may expect to spend on the different aspects of the EUDAMED portal.

Manual Entry, XML Bulk Upload or M2M API

The data can be uploaded in many ways to the EUDAMED portal. You can enter it manually, use an XML bulk upload or use an M2M API. From a practical perspective, although M2M or XML bulk upload may seem to be the right choice, we have found that manual entry is sometimes better. While it takes time, once it is completed, it is done. Otherwise, we have to wait for the portal and other systems to work properly with M2M or XML.

Importer Actor Profiles and UDI-DI Linking

Morulaa can support all three formats. While it is important for the manufacturer to register on the EUDAMED portal, importers must also have a valid actor profile and link themselves to the UDI-DI for the products they place on the Union market.

Sources

• European Commission: EUDAMED overview

• European Commission: first four EUDAMED modules mandatory from 28 May 2026

• Regulation (EU) 2024/1860

• European Commission: Unique Device Identifier and Master UDI-DI

• European Commission: MDCG endorsed guidance

• Swissmedic: swissdamed device registration