Device distributors and importers

Operators

This page contains information about the requirements applicable to importers and distributors of medical devices.

To learn which requirements apply to you, it is important to determine your role under the Regulation. Please note that one operator can have only one role per a certain device under the Regulation. For example, a manufacturer can distribute a device, but that operator does not meet the definition of both a manufacturer and a distributor/importer.

NOTE! Due to the different dates of application of the new EU Regulations, the regulation of medical devices and that of IVDs differ somewhat during the transitional period.

Device distributors and importers

‘Importer’ means any operator established within the Union that places a device from a third country on the Union market. In other words, the device manufacturer is established outside the EU, e.g. in Asia or Northern America. Please note that an operator who imports devices from Sweden to Finland, for example, is not an importer but a distributor. See the definition of a manufacturer in the Regulations: MDR: Article 2(33); IVDR: Article 2(26). Go to the Importers page
A distributor supplies devices to other operators or consumers in Finland. A distributor may import equipment from the EU area or from domestic operators. For example, pharmacies and retailers can be distributors. See the definition of a distributor in the Regulations: MDR: Article 2(34); IVDR: Article 2(27). Go to the Distributors page
‘Manufacturer’ is an operator who manufactures or has a device manufactured, and markets that device under its name or trade mark. See the definition of a manufacturer in the Regulations: MDR: Article 2(30); IVDR: Article 2(23). Go to the Device manufacturers page.
‘Authorised representative’ means an operator established within the Union who is responsible for certain obligations of a manufacturer located outside the Union. NOTE! Here, ‘authorisation’ does not refer to exclusive sales right, the right to sell a device or any other commercial rights. See the definition of an authorised representative in the Regulations: MDR: Article 2(32); IVDR: Article 2(25).

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