swissdamed and direct imports

Must a Swiss hospital or medical practice register a CE-compliant medical device in swissdamed if it is sourced directly from the EU? Not automatically. The decisive factor is not the border crossing alone, but whether the device is placed on the market in Switzerland or used directly within the same legal entity.

Mandatory device registration in swissdamed raises new questions of regulatory classification in practice. It is often assumed that every medical device sourced from abroad must be registered in swissdamed by 1 January 2027 at the latest. However, this statement is too broad for direct sourcing by professionals and healthcare institutions.

Swissmedic distinguishes between placing a device on the market in Switzerland and direct use of a device sourced from abroad. This distinction determines whether a healthcare institution is considered an importer and whether the specific transaction requires device registration in swissdamed.

When is direct sourcing considered direct use?

This special case concerns professionals and healthcare institutions that source a device from abroad and use it directly without making it available on the Swiss market. For example, a hospital may order a medical device directly from a manufacturer in the EU and use it within the same legal entity to treat its own patients.

Internal distribution to several departments or sites may also remain within this situation, provided that these organisational units belong to the same legal entity. The decisive factor is therefore not only where the device is used, but which legal entity receives and uses it.

Why CE marking alone does not answer the question

CE marking is an important prerequisite, but it is not sufficient as the only check for the internal approval of a direct import. Under Art. 70 MedDO, the professional or healthcare institution using the device assumes responsibility for the conformity of the device sourced directly from abroad.

In practice, the institution should therefore document whether the device bears a conformity mark recognised in Switzerland and whether the prescribed conformity assessment procedure has been completed. Depending on the device, risk class and procurement situation, additional evidence and internal approvals may be required.

What obligations remain for hospitals and medical practices?

Even if a direct import for the institution’s own use does not trigger device registration in swissdamed by the healthcare institution, the procurement process should be secured from a regulatory perspective. Depending on the situation, this includes in particular:

• checking the conformity mark and the prescribed conformity assessment procedure,
• checking the intended purpose, labelling and required device information,
• documenting the procurement decision and the evidence reviewed internally,
• ensuring vigilance, safety and traceability processes,
• observing additional UDI record-keeping obligations, particularly for class III implantable devices,
• reassessing the regulatory role as soon as devices are supplied to another legal entity.

For the specific direct import for the institution’s own use, a Swiss authorised representative is not mandatory under the therapeutic products law classification described by Swissmedic. However, because of the associated risks, Swissmedic recommends procurement without a Swiss authorised representative only in justified exceptional cases.

When does a healthcare institution become an importer?

The boundary is crossed when a device sourced from abroad is supplied to another Swiss legal entity. This may be the case, for example, where a central purchasing organisation or hospital procures devices and subsequently supplies them to a legally independent hospital. Whether the supply is made for payment or free of charge is not decisive for this classification.

This generally constitutes placing the device on the market, and the importing organisation must assess its role and the associated obligations. These may include registration as an economic operator with a CHRN and linking the organisation to the affected devices in swissdamed.

What does the deadline of 31 December 2026 mean?

Since 1 July 2026, mandatory swissdamed registration has applied to devices and systems and procedure packs placed on the market in Switzerland. A general transition period for device registration runs until 31 December 2026.

The frequently used statement “From 2027, only medical devices registered in swissdamed may be imported into Swiss hospitals” is therefore too broad. The correct position is: Devices placed on the market in Switzerland must generally be correctly registered in swissdamed. Direct sourcing by a professional or healthcare institution for immediate use by that same institution must be distinguished from this, because it does not constitute placing the device on the market in the situation described above.

Importers are also subject to a separate rule: they do not register the device themselves, but link their actor to the device that has already been registered. Under Swissmedic’s current schedule, the technical linking function is being rolled out in stages from autumn 2026. Missing links attributable solely to the function not yet being available are expected to be completed by 1 April 2027 after the function becomes available.

Five questions for an internal role assessment

1. Who procures the device? A professional, hospital, purchasing organisation or independent trading company?
2. Who uses the device? The procuring legal entity itself or another organisation?
3. Is the device supplied onward? Even a free supply to another legal entity may be relevant.
4. Is conformity sufficiently documented? CE marking, conformity assessment and device-specific evidence must be considered together.
5. Who is responsible for swissdamed? The manufacturer or CH-REP for device registration; the importer for the CHRN and device linking; and the healthcare institution for its user and procurement obligations.

Frequently asked questions about direct imports and swissdamed