EUDAMED & swissdamed: Mandatory Registration for 2026

Preparing for EUDAMED & swissdamed

As global regulatory systems continue evolving, medical device manufacturers must stay ahead of changing requirements to maintain market access. In our recent webinar, our regulatory team discussed the upcoming UDI registration obligations for both EUDAMED and Switzerland’s Swissdamed system, highlighting what companies need to do now to prepare.

Below is a summary of the key topics covered during the session. You can also watch the full webinar recording and review the slides for a deeper walkthrough of the requirements and practical implementation steps.

For more information about MedEnvoy’s EUDAMED and swissdamed Registration Management service, click here.

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Understanding the Relationship Between Swissdamed and EUDAMED

Both Swissdamed and EUDAMED rely on the same underlying Unique Device Identification (UDI) framework, which helps ensure device traceability, transparency, and regulatory oversight.

Because these systems share a common data structure, manufacturers operating in both the European Union and Switzerland can take advantage of a major efficiency: maintaining one centralized UDI data set that can be used for both databases.

However, it’s important to note that the systems do not automatically synchronize data. Manufacturers must still submit information separately to each system, even if the underlying data remains the same.

Why Data Accuracy Matters More Than Ever

One of the main themes discussed in the webinar was the importance of data governance and consistency.

Errors or inconsistencies between submissions can create several risks, including:

Market Access Risks

Importers and distributors may be required to verify device registration before placing products on the market. If registration data is incomplete or inconsistent, it can disrupt supply chains and delay product availability.

Regulatory Compliance Issues

Incorrect device descriptions, mismatched economic operator roles, or inconsistent UDI assignments can lead to regulatory complications across multiple markets.

Reputational Risk

Both EUDAMED and Swissdamed include public-facing portals where device information can be visible to healthcare professionals and other stakeholders. Incorrect or incomplete data may undermine confidence in a manufacturer’s products or regulatory compliance.

For these reasons, we strongly recommend performing a comprehensive data audit ahead of key regulatory deadlines.

Leveraging a Single UDI Data Set

A common question during the webinar was whether manufacturers need to maintain separate UDI data sets for EUDAMED and Swissdamed.

The good news is that a single master UDI data set can serve both systems.

In practice, this means manufacturers can:

1. Maintain UDI data within their internal master data system.
2. Use that data to populate EUDAMED’s UDI device registration module.
3. Export the XML data from EUDAMED.
4. Use the same data set when preparing submissions for Swissdamed.

While the submissions themselves remain separate, the core device information—such as device identifiers, packaging levels, and UDI structure—only needs to be created and maintained once.

Swiss-Specific Data Considerations

Although the core UDI data structure aligns with EUDAMED, Swissdamed may require additional Switzerland-specific data fields.

These may include items such as:

• Swiss-specific labeling requirements
• Language considerations
• Market-specific compliance elements

Manufacturers should ensure these fields are addressed as part of their data preparation process to avoid submission issues.

Best Practices for Preparing Your UDI Data

To support successful registration in both systems, we recommend the following steps:

Conduct a UDI Data Audit

Review key device information for accuracy and consistency across systems, including:

• Device descriptions
• UDI assignments
• Economic operator roles
• Certificate references

Centralize Your Master Data

Maintaining a single authoritative UDI data source helps prevent inconsistencies and simplifies regulatory submissions.

Establish Clear Data Governance

Define internal ownership for maintaining and updating UDI data, ensuring that changes are properly controlled and documented.

Final Takeaways

As regulatory databases like EUDAMED and Swissdamed become increasingly central to device compliance, manufacturers must treat UDI data management as a core regulatory function rather than an administrative task.

By maintaining a well-governed master UDI data set and conducting proactive data reviews, companies can reduce regulatory risk while streamlining submissions across multiple jurisdictions.

At MedEnvoy, we provide EUDAMED and swissdamed Registration Services to help manufacturers manage actor and device registrations, maintain compliance, and streamline submissions across multiple markets. If you’d like support in preparing your data or handling registrations, our Regulatory Affairs experts are here to help. Contact us today.

About the Speaker

Brittany Dunning

Regulatory Affairs Consultant, MedEnvoy Global