UDI to swissdamed: Data Fields and Choosing among Three Registration Routes

This article is issue 23 of Volume 3, Registration Dossiers and Technical Requirements, of the 50-article series on medical device registration in Switzerland. Together with the other nine issues in this volume it forms a complete deliverable on this topic; the publication timestamp, issue number, title and unique URL are shown in the table below.

1. Key takeaways

In Switzerland, the UDI-DI carries two roles: it is the registration unit in swissdamed, and it is the billing unit for the device registration fee. The UDI Devices module opens for voluntary registration from 18 August 2025 until 30 June 2026; from 1 July 2026 registration becomes mandatory, with a transition period ending on 31 December 2026. The same data set must enter two systems: there is no interface between swissdamed and EUDAMED, and no automatic synchronisation, so a duplicate upload is unavoidable. There are three registration routes: online editing, XML upload and M2M (machine-to-machine). The only criterion for choosing among them is the number of your UDI-DIs and the frequency of changes.

2. Legal basis

3. Expert insights

1. The absence of an interface is a cost variable, not a technical detail. No data interface exists between swissdamed and EUDAMED, the two systems cannot synchronise automatically, and the same batch of UDI-DIs must be uploaded twice. The direct consequence is that the correctness of EUDAMED data cannot vouch for the correctness of swissdamed data, and discrepancies in field definitions between the two sides are amplified at year-end billing. Under Annex 2 of FeeO-Swissmedic, the first UDI-DI costs CHF 200, each additional UDI-DI in the same calendar year costs CHF 20, and the annual cap per manufacturer/SPPP is CHF 10,000 (reached at 491 devices, with device 492 onwards no longer charged). In other words, duplicate registrations and re-registration after invalidation land directly on the invoice — re-registration after invalidation requires a new fee, while data updates themselves are free of charge.

2. The dividing line between the three routes is volume, not preference. Online editing suits entities with few UDI-DIs and sparse changes; its strengths are zero development cost and immediately visible field validation. XML upload suits mid-sized portfolios that already have EUDAMED data structures: existing XML generation logic can be reused, but field mapping must be checked so nothing is lost. M2M suits manufacturers with large volumes and frequent changes: system-to-system integration replaces manual upload, the upfront development investment is the highest, but the marginal cost is pushed close to zero. The common selection mistake in practice is to launch first and choose the route later — by the time M2M is added, several rounds of manual upload have already become sunk cost (practical estimate).

3. The year-end date determines the shape of the invoice. The first billing date is 31 December 2026, covering all UDI-DIs with the status On the market on that date; UDI-DIs with the status No longer placed on the market are not charged. This gives companies a clear but one-time window: marking discontinued product lines as No longer placed on the market before 31 December 2026 directly reduces the number of items on the first invoice. From 1 January 2027, conventional invoices are issued for new registrations during the year. There is a counterweight here: marking a device as no longer placed on the market is a status action, and if the product is later relaunched, re-registration requires a new fee. So delisting decisions must rest on genuine commercial judgement, not on the wish to save one CHF 20 item.

4. Practical recommendations

1. Run a full UDI-DI inventory first, splitting devices into three categories: on the market, discontinued but still placed on the market, and withdrawn; complete status marking for withdrawn items before the first billing date.
2. Select the route by UDI-DI count and annual change frequency: single digits use online editing, tens to hundreds use XML upload, and for several hundred or high-frequency changes evaluate M2M.
3. Build a field mapping table between EUDAMED and swissdamed and update both sides in step; never assume that one synchronisation remains valid forever.
4. Fees are consolidated at the manufacturer/SPPP level rather than the CH-REP level; for entities outside Switzerland, invoices are sent to their CH-REP, so agree the invoice receipt and forwarding process with the representative in advance.
5. Devices subject to serious incident, FSCA or trend reporting obligations have no transition period from 1 July 2026 and must be registered immediately; prioritise them, as they do not benefit from the year-end window.

5. Verification checklist

• □ A full UDI-DI inventory is complete, distinguishing on the market, discontinued but still placed, and withdrawn
• □ It is confirmed that data are uploaded separately to swissdamed and EUDAMED, with no step relying on automatic synchronisation
• □ One route among online editing, XML upload and M2M has been selected by volume and change frequency, with the reasons recorded
• □ A field mapping table between EUDAMED and swissdamed exists, with a named maintainer
• □ Annual fees are calculated: CHF 200 for the first item plus CHF 20 per item, and checked against the CHF 10,000 cap
• □ The invoice recipient and the CH-REP forwarding process are agreed in the mandate

Legal information verified as of 29 October 2026.

GRZAN offers registration documentation and conformity file support for the Swiss market, including swissdamed registration in all three routes, EUDAMED-to-swissdamed field mapping, UDI-DI inventory management and fee planning under FeeO-Swissmedic. Our team keeps your device registration data complete and billable items under control. For assistance, contact GRZAN at info@grzanglobal.com.