Importer Services

Importers and distributors have obligations concerning MDD/AIMDD/IVDD devices. While Art. 53 and 54 of the MedDO, and Art. 46 and 47 of the IvDO apply directly to MDR and IVDR devices, for MDD/AIMDD/IVDD devices, these obligations should be considered alongside transitional provisions outlined in Art. 101 para. 1, 1bis, and 1ter of the MedDO or Art. 82 para. 1 of the IvDO. 

These transitional provisions allow MDD/AIMDD/IVDD devices to be placed on the market even if they don’t fully meet MDR/IVDR requirements. However, certain provisions of MDR/IVDR are still applicable, such as post-market surveillance, market surveillance, vigilance, and registration of economic operators and devices.  

The transitional provisions may result in expired EC certificates for medical devices (excluding in vitro diagnostic medical devices). As a CH-REP or importer, it’s your responsibility to ensure that these certificates still meet legal requirements to be recognized as valid. 

You must verify if valid certificates of conformity (EC certificates) exist. The importer needs to demonstrate that the conformity assessment was conducted by the manufacturer and that the device complies. If there are doubts about a device’s conformity, it cannot be placed on the market until brought into compliance.  Expired certificates don’t automatically meet legal requirements for extension, so CH-REPs and importers must assess their plausibility. 

This includes checking if the manufacturer declares compliance for extending the certificate’s validity or if there’s a confirmation from the designated/notified body regarding an application for a conformity assessment procedure.  Swiss medic follows European practices in interpreting relevant provisions. Additional guidance on extending the validity of certificates issued under previous legislation is available in the European Commission’s Q&A Rev. 14. 

If a company imports a device from a manufacturer in another country and also acts as the CH-REP mandated by the manufacturer, it must fulfill obligations as both the CH-REP and importer. This entails registering separately as both an importer and CH-REP, resulting in the company receiving two CHRN.   

As a manufacturer, CH-REP, or importer of both in vitro diagnostic devices and classic medical devices, you only need to register once with Swissmedic. Any subsequent changes, such as updates to your address, can be communicated to Swissmedic through a change notification. If devices are directly dispensed to end customers in Switzerland without involving distributors in the distribution chain, simply indicating the importer on customs documents, invoices, or other accompanying documents that don’t accompany the devices when they’re placed on the market doesn’t fulfill the declaration requirement outlined in Art. 53 para. 2 MedDO / Art. 46 para. 2 IvDO.   

Instead, when a device is transferred or ceded in Switzerland, the importer must be clearly identifiable along the supply chain. This can be achieved by stating the importer on the device itself, its packaging, or on a document accompanying the device at the point of market placement. 

Reference: https://www.swissmedic.ch/swissmedic/en/home/medical-devices/market-access/dispensing—imports.html