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Importer Services

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Importer Services

Importer Services

The importer, whether in the European Union (EU) or Switzerland, is responsible for ensuring that medical devices placed on their respective markets comply with relevant regulations. In the EU, the importer verifies compliance with the Medical Device Regulation (MDR), including CE marking, conformity documentation, manufacturer identification, and proper labeling. They must also register with EUDAMED, ensure proper storage and transport conditions, and handle complaints and non-conformities.

Similarly, in Switzerland, importers must verify conformity with Swiss regulations, including conformity marking, proper documentation, labeling, and compliance with transitional provisions if applicable. They must cooperate with relevant parties, register complaints and incidents, assist with corrective actions, and retain documentation for specified periods.

Swiss Importer

Authorized representatives and importers in Switzerland need to register with Swissmedic, but they don’t require a license. When determining transition periods for placing MDD class I devices and “other IVD”-class IVDD devices on the market, first classify them under the new regulations (MDR, IVDR). Once classified, check if any deadlines apply based on the classification. 

For example, under MDR, reusable surgical instruments now require a certificate, triggering applicable deadlines. Similarly, under IVDR, some in-vitro diagnostic tests previously exempt now require certification, thus affecting deadlines.

 

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

 

EU Importer

Information covered in this document includes detailed explanations regarding the operational and practical implementation of Articles 13 and 14, along with other associated obligations for importers and distributors under the Regulations. Activities outlined in Article 16 of the Regulations are addressed in separate guidance documents such as MDCG 2018-6, MDCG 2021-232, and MDCG 2021-263. 

The definition of ‘importer’ and ‘distributor’ as outlined in Article 2 of the MDR (and corresponding IVDR articles) is as follows: 

An ‘importer’ refers to any natural or legal person within the Union who places a device from a third country onto the Union market.  

A ‘distributor’ pertains to any natural or legal person within the supply chain, excluding the manufacturer or importer, who makes a device available on the market until the point of putting it into service. The definitions of importer and distributor are to be read in conjunction with the following definitions: Article 2(27) ‘making available on the market’ means any supply of a device, other than an investigational device, for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge;. Article 2 (28) ‘placing on the market’ means the first making available of a device, other than an investigational device, on the Union market; Article 2(29) ‘putting into service’ means the stage at which a device, other than an investigational device, has been made available to the final user as being ready for use on the Union market for the first time for its intended purpose. For further horizontal elaborations on the above concepts, please consult the Blue Guide8 based on the principles of the New Legislative Framework. 

The distinction between a distributor and an importer is determined by the concept of ‘placing on the market’. When a natural or legal person within the Union acquires a device from an economic operator in a third country and introduces that specific device onto the Union market (i.e., the initial act of making it available), they function as the importer of that individual device. On the other hand, if a natural or legal person within the Union acquires devices from importers, distributors, or manufacturers within the Union and subsequently distributes these devices to other entities (i.e., engaging in the process of “making available” after the initial introduction), they are regarded as distributors. 

It’s important to note that a device purchased by a consumer in a third country and brought into the Union for personal use (outside of commercial activities) is not considered as being placed on the market. 

Reference: https://health.ec.europa.eu/system/files/2023-12/mdcg_2021-27_en.pdf

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