Swissmedic Updates Information Sheet on Procurement of Medical Devices in Healthcare Institutions
Swissmedic has updated its information sheet “Procurement of medical devices in healthcare institutions”, identification number MU600_00_006, version 6.1, valid from 11 August 2026.
The document is aimed at healthcare institutions, including hospitals, practices and purchasing organisations, and describes the documentation and evidence used to demonstrate the conformity of medical devices.
Medical Device Regulation in Switzerland
Swissmedic explains that Switzerland’s revised medical device legislation is based on the EU regulations for medical devices and in vitro diagnostic medical devices, namely the EU MDR and EU IVDR.
The document also notes that Switzerland has introduced measures following the non-update of the Swiss-EU Mutual Recognition Agreement, including CH-REP designation for manufacturers domiciled outside Switzerland, registration of economic operators with Swissmedic, reporting of serious incidents to Swissmedic and recognition of EU certificates of conformity in Switzerland.
swissdamed and UDI
The information sheet highlights the role of the Unique Device Identifier in ensuring identification and traceability of medical devices, including IVDs, throughout the supply chain and lifecycle.
Device registration in swissdamed is mandatory from 1 July 2026 and must be fulfilled by the end of 2026. The recorded device information is publicly available, helping healthcare institutions check devices to be procured.
Healthcare institutions must also store and keep the UDI for class III implants with which they have been supplied or which they have supplied, preferably by electronic means.
Conformity and Authorisation of Medical Devices
Swissmedic clarifies that, unlike medicinal products, medical devices are not officially authorised in Switzerland or across Europe.
Instead, every medical device must satisfy applicable general safety and performance requirements. Manufacturers assess conformity and, depending on the device risk class, may need to involve a designated or notified body. For moderate- and high-risk devices, the designated body reviews and monitors the device and the manufacturer’s quality management system.
CH-REP and Swiss Importer Information
Manufacturers domiciled outside Switzerland must designate a Swiss authorised representative, or CH-REP, if they wish to place medical devices, including IVDs, on the Swiss market.
The Swiss importer must also be shown on medical devices, their packaging or an accompanying document. Swissmedic notes that the Swiss importer should not be confused with the EU importer.
Duty of Care for Healthcare Institutions
The information sheet emphasises that manufacturers remain responsible for the quality and conformity of their devices, but healthcare institutions have significant responsibility when selecting suppliers and medical devices.
Anyone handling medical devices is subject to a duty of care and must take measures required by the state of the art to ensure that health is not jeopardised. Only medical devices bearing a valid conformity marking, such as a CE mark or MD mark, may be used.
Direct Imports by Healthcare Professionals
Swissmedic explains that when professionals or healthcare institutions import CE-conforming medical devices and use them directly, without making them available on the Swiss market, they are not considered to have placed the devices on the market.
However, the professional or healthcare institution remains responsible for the conformity of the device and must check that it carries a recognised conformity marking and that the appropriate conformity assessment procedure has been carried out.
Swissmedic also warns that where devices are imported without a Swiss authorised representative and used directly, no Swiss economic operator is responsible for formal and safety-related aspects. In such cases, healthcare professionals and institutions take full responsibility for information flow, corrective actions and liability questions.
New Procurement-Related Requirements
The updated information sheet identifies new requirements with implications for procurement in healthcare institutions.
These include:
UDI traceability for at least class III implantable medical devices;
implant cards for implantable EU MDR devices, provided in the three national languages;
the prohibition of reprocessed single-use devices in Switzerland.
Healthcare institutions must enter patient identification details on implant cards and provide the cards to patients, which may affect internal logistics for devices and enclosed implant cards.
Quality Deficiencies and Non-Conforming Devices
Healthcare institutions must report serious incidents to the supplier and to Swissmedic under materiovigilance requirements.
Swissmedic also asks healthcare institutions to notify it if irregularities are discovered during procurement, for example where there is suspicion that EU certificates are counterfeit.
Impact on Medical Device and IVD Manufacturers
For medical device and IVD manufacturers supplying the Swiss market, the updated information sheet reinforces the importance of providing clear, complete and verifiable conformity documentation to healthcare institutions.
Manufacturers should pay particular attention to:
valid CE or MD marking;
declarations of conformity;
EU certificates where required;
CH-REP and Swiss importer information;
UDI assignment and swissdamed registration;
conformity evidence under MedDO and IvDO;
implant card availability where applicable;
product traceability documentation;
communication of field safety corrective actions;
supplier support for healthcare institution procurement checks.
For manufacturers and economic operators, the guidance highlights that procurement readiness is increasingly linked to transparency, traceability and the ability to provide healthcare institutions with reliable evidence of device conformity.
