The introduction of swissdamed, Switzerland’s medical device registration database, has prompted both anticipation and concern within the medtech industry. In May 2025, MedTech Europe’s Working Group submitted a policy paper highlighting key challenges manufacturers face with the current technical setup of swissdamed.

Industry Concerns

The core issue identified by the industry is the lack of a fully automated machine-to-machine (M2M) data submission capability. Currently, swissdamed relies on a “bulk upload” process that requires manual submission of XML files. While aligned with EUDAMED’s XML upload format (i.e. organizations can use EUDAMED’s ‘GET DEVICE’ or ‘POST DEVICE’ XML format), economic operators with large device volumes have expressed concern that the process is time-consuming and labor-intensive.

Several constraints were noted:

• EUDAMED limitations: Not all devices will be available for bulk download by July/December 2026, particularly high-risk devices awaiting certificate uploads by Notified Bodies. The platform also restricts downloads to small batches (20 pages), making it difficult to download large volumes of devices from EUDAMED and upload to swissdamed efficiently.
• swissdamed limitations: The bulk XML upload function is not truly bulk as devices must be uploaded one-by-one, and with no clear indication that XML upload can be used for ongoing maintenance. Furthermore, additional data for Market Status needs to be updated manually. There is also legitimate concern that there is no playground environment available for industry testing and validation. With all these limitations and in the absence of clear technical documentation and data validation rules, the industry has raised concerns about the UDI compliance deadlines set by Swissmedic.

MedTech Europe recommended leveraging the experience of EUDAMED M2M connections, providing full technical documentation, implementing a test/playground environment, and developing a real M2M solution to streamline data submission. They also requested an extension of mandatory registration deadlines to allow sufficient preparation time.

Swissmedic’s Response

Swissmedic acknowledged receipt of the policy paper and expressed appreciation for the proactive industry engagement. The regulator confirmed that many concerns had already been anticipated and addressed.

Key points from Swissmedic’s response include:

• Communication on timelines and technical documentation will intensify in the coming months to keep the industry informed.
• swissdamed is designed to minimize stakeholder burden by largely adhering to EUDAMED’s data model and only requiring three additional Swiss-specific data elements.
• Swissmedic will introduce a playground environment to allow the industry to test. New features will be available there before production release, and users are encouraged to provide feedback.
• The first swissdamed production release will not include M2M functionality, which is under development and planned for 2026.
• The registration obligation for swissdamed is scheduled to take effect after the corresponding EUDAMED requirements, allowing economic operators to leverage existing EUDAMED data.
• Swissmedic continues to monitor EUDAMED developments closely to ensure a smooth transition.

Looking Ahead

While industry concerns highlight the practical challenges of implementing swissdamed, Swissmedic emphasizes its commitment to reducing regulatory burden to economic operators and ensuring a clear, predictable submission process aligned with EUDAMED. Ongoing communication and collaboration between the regulator and industry stakeholders will be crucial to meet compliance timelines and maintain accurate device data in the Swiss market.