Swiss Importer
Authorized representatives and importers in Switzerland must register with Swissmedic but do not 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 MDR or IVDR. Once classified, check if deadlines apply based on the new classification.
For example: Under MDR, reusable surgical instruments now require a certificate, triggering applicable deadlines. Under IVDR, some in-vitro diagnostic tests previously exempt now require certification, affecting their deadlines.
Importers and distributors have obligations concerning MDD/AIMDD/IVDD devices. While certain articles of the MedDO and IvDO apply directly to MDR and IVDR devices, the same obligations also apply to legacy devices when considered alongside transitional provisions.
These transitional provisions allow MDD/AIMDD/IVDD devices to be placed on the market even if they do not fully meet MDR/IVDR requirements. However, MDR/IVDR requirements related to post-market surveillance, market surveillance, vigilance, and registration of economic operators and devices still apply.
Transitional provisions may result in expired EC certificates for medical devices. Importers and CH-REPs must ensure that such certificates still meet legal requirements to be recognized as valid.
Importers must verify that valid EC certificates exist, ensure conformity assessment was performed, and confirm the device complies. Devices with doubtful compliance cannot be placed on the market.
Expired certificates are not automatically eligible for extension—CH-REPs and importers must assess their plausibility. This includes verifying declarations from the manufacturer or confirmation from the notified body that a conformity assessment application has been submitted.
Swissmedic follows European practices in interpreting these provisions. Additional guidance is available in the European Commission’s Q&A Rev. 14.
If a company imports a device and also acts as the CH-REP, it must fulfill both roles and register separately with Swissmedic, resulting in two CHRNs.
Manufacturers, CH-REPs, or importers of both IVDs and classic medical devices only need to register once with Swissmedic. Updates such as address changes can be made through a change notification.
If devices are supplied directly to customers in Switzerland without distributors, indicating the importer only on customs documents or invoices does not fulfill the declaration requirement. The importer must be identifiable on the device, its packaging, or a document accompanying the device at the time of market placement.
When a device is transferred in Switzerland, the importer must remain clearly identifiable along the supply chain.
Reference:
Swissmedic – Dispensing & Imports
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 Guide 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
