Swissdamed to Align with EUDAMED XML Format

Swissmedic has announced that the Swissdamed registration system will use the same XML file format as EUDAMED for its Device Module. This update presents a unique opportunity for medical device companies navigating compliance in both the EU and Swiss markets, as it allows for a more streamlined registration process across these regions. 

Preparing for the Swissdamed Transition Deadline in 2025 

Swissdamed registration will remain voluntary until 2025, but we encourage companies to prepare early. By acting promptly, you can avoid the rush when the mandatory deadline approaches and ensure a smooth compliance process. Early registration will help mitigate potential bottlenecks.

MedEnvoy’s Dual Registration Support 

With this alignment between Swissdamed and EUDAMED, MedEnvoy is well-equipped to support a dual registration process for both the EU and Swiss markets. For clients already registered with EUDAMED, this compatibility means no additional data entry is required—MedEnvoy already holds the necessary device data and can integrate it seamlessly into Swissdamed. 

For those who have not yet partnered with MedEnvoy for EUDAMED registration, we will soon offer Swissdamed registration management, allowing us to register and update device information in Swissdamed on your behalf. We leverage our established IT platform, Glorias, which is already successfully used for EUDAMED registration management. Contracting both services with MedEnvoy provides a significant advantage, as there is considerable overlap in the data, streamlining your compliance process and reducing administrative efforts.

Our team’s deep understanding of both EU and Swiss compliance requirements, along with our established data management systems, allows us to offer this service at a fair price. MedEnvoy is committed to providing efficient and straightforward compliance solutions to help clients manage the complexities of multi-market regulatory requirements. 

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If you’re interested in learning more about Swissdamed registration or have questions about preparing for the upcoming 2025 deadline, feel free to reach out to our team. MedEnvoy is here to make compliance easy and reliable. 

Learn how MedEnvoy can assist you:

• • • Swiss Authorized Representative
    • Swiss Regulatory Importer
    • EUDAMED Registration Management