Background

‘swissdamed’

Swissmedic is developing a centralized registration database, modeled off of EUDAMED, called ‘swissdamed’. It will consist of two registration modules: Actor & UDI/Devices

The Actor registration module became mandatory on 6 August 2024. And the UDI/Device registration module is expected to become mandatory starting 1 July 2026, followed by a six-month transition period. However, companies can voluntarily register their devices early, once the module goes live.

Systems/Procedure Packs

In Switzerland, Systems/Procedure Packs are regulated similarly as they are under the EU MDR. However, there are some differences, which are outlined under the Swiss MedDO.

One significant difference is that non-EU System/Procedure Pack Producers (SPPPs) are not required to appoint an EU Authorized Representative. However, non-Swiss SPPPs are required to appoint a Swiss Authorized Representative.

Until now, Swissmedic has published limited additional guidance on SPPP requirements in Switzerland.

eIFU Legislation

The EU recently amended its eIFU legislation to allow electronic instructions for use, for all professional use medical devices.

Art. 95(1) of the Swiss MedDO lets Swissmedic automatically apply new EU MDR Commission Implementing Acts, with no extra Swiss legislative process needed.  

Manufacturer Incident Report (MIR) Form

Swissmedic uses the EU Manufacturer Incident Report (MIR) form for vigilance reporting. The official version of the form is located on Swissmedic’s vigilance webpage, plus guidance on how to appropriately fill it out for Switzerland.

‘swissdamed’ Registration Module Update

Swissmedic’s announcement on the UDI/Device registration module for voluntary use is: HERE

Per the announcement, “since August 2025, it has been possible to register [Regulation] devices, systems and procedure packs on a voluntary basis”. Corresponding User Manuals and related materials were published 18 August 2025. Please visit this post for more information: Overview of New swissdamed UDI/Devices Module

Per Swissmedic’s announcement, legacy device and Master UDI-DI registration will not be possible in this first version of the UDI/Devices module. However, it will be available sometime before the 1 July 2026 mandatory use date.

Once registered in swissdamed, devices will be publicly viewable.

Current Device Registration Requirements

Until the swissdamed UDI/Device registration module becomes mandatory starting 1 July 2026, the current registration requirements still apply.

Currently, only a subset of devices require registration in Switzerland:

New System/Procedure Pack Guidance

Swissmedic’s Info Sheet on Systems/Procedure Packs is available: HERE

The guidance notably clarifies that, in addition to the System/Procedure Pack itself, each foreign-manufactured device in the pack must have its own Swiss Authorized Representative (CH-REP).

“Individual medical devices that are part of an SPP are placed on the market in Switzerland. All the individual medical devices included in an SPP must fulfill all legal requirements in Switzerland. Among other things, a CH-REP must be mandated for every individual medical device from a foreign manufacturer included in an SPP.”

The Info Sheet also clarifies other minor requirements. For example, where to place the CH-REP’s information on the System/Procedure Pack labeling:

“SPPs from foreign assemblers that are placed on the market in Switzerland must include in their labelling the details of the CH-REP for the SPP (section 5.3). For SPPs produced by foreign assemblers under the old legislation [legacy devices], the details of the CH-REP for the SPP must be provided on the label or in the instructions for use.”

Other notable swissdamed FAQs are provided below:

Who is able to register UDIs in swissdamed: Manufacturers (including manufacturers of systems and procedure packs) and their authorised representatives are able to register UDIs in swissdamed as soon as they themselves are registered as “economic operators” in swissdamed.

Are there products for which the UDIs must be registered immediately as of 1 July 2026 without a transitional period: Yes. UDIs for products that have to be reported to Swissmedic due to a serious incident, a field safety corrective action or a trend (vigilance) are subject to immediate registration from 1 July 2026. In these cases, no transitional period applies. “Old devices” are exempt from the UDI registration in swissdamed. However, even for “old devices” serious incidents, field safety corrective action or trends (vigilance) shall be reported to Swissmedic.

Will the European Medical Device Nomenclature (EMDN) be used in swissdamed or will a different nomenclature be used: In swissdamed, only the EMDN nomenclature will be used.

Is data from EUDAMED being migrated to swissdamed by Swissmedic or is this the responsibility of the economic operators: The data has to be uploaded into swissdamed by the relevant economic operators. An interface between swissdamed and EUDAMED does not exist at this time. Therefore, Swissmedic cannot transfer or synchronize any data from EUDAMED.

For more information, visit the following Knowledge Center page: EU, Swiss, UK Guide on Systems/Procedure Packs and Kits

eIFUs in Switzerland

Swissmedic confirmed that the amended EU eIFU legislation is adopted: HERE

For an overview of the new eIFU requirements, please read: eIFUs Now Allowed for All Professional Use Devices

Updated Swiss MIR Form

Recently the EU made minor changes to its Manufacturer Incident Report (MIR) form.

Accordingly, Swissmedic has updated its controlled version to align with the EU. It is available: HERE

Scroll down to document “MU680_20_017e_FO Manufacturer Incident Report (MIR), V7.3.1 (PDF, 229 kB, 21.07.2025)”.

The associated Swiss MIR form guidance remains the same: “MU680_20_815e_WL_Guidance document CH Guide Manufacturer Incident Report (MIR) (PDF, 409 kB, 06.05.2025)”. It is available directly underneath the MIR forms.