Distributors

Medical device means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:

• diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease,
• diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability,
• investigation, replacement or modification of the anatomy or of a physiological or pathological process or state,
• providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations,

and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means.

The following products shall also be deemed to be medical devices:

• devices for the control or support of conception;
• products specifically intended for the cleaning, disinfection or sterilisation of devices as referred to in Article 1(4) and of those referred to in the first paragraph of this point.

Examples of medical devices include a blood pressure monitor, a patch, spectacles, a hearing aid, and condoms. Pregnancy and laboratory tests are the so-called in vitro (IVD) medical devices.

Medical devices do not include items such as hygiene products (e.g. menstruation bandages), wellness meters (e.g. pulse meters), personal protective equipment (e.g. respirators) or hand disinfectants.

Only medical devices that are in conformity with the requirements may be placed on the market and put into service in Finland and in the EU area. Before placing a device on the market, the manufacturer is required to verify its safety, suitability for the intended use and performance. A CE marking is a proof that the device is in conformity with the applicable requirements. In addition to the CE marking shown on the packaging, device and instructions for use, the manufacturer must prepare a Declaration of Conformity (DoC). 

Devices of a higher risk category are evaluated by an external assessment body, a notified body. In this case, the four-digit code of the notified body that evaluated the device must also be shown next to the CE marking (e.g. CE 9876).

The free movement of goods in the EU area applies to medical devices that bear an appropriate CE marking.

If the manufacturer is based outside the EU, it is required to also have a European authorised representative (EAR/EC Rep). The authorised representative registers the device in Europe and serves, in accordance with the European device legislation, as the manufacturer's representative in regulatory matters in the EU/EEA (different from the manufacturer’s commercial representative). 

If the distributor distributes devices whose manufacturer is established outside the EU, the distributor shall check that, in addition to the manufacturer's information, the contact information of the authorised representative and the importer can be appropriately found on the labelling of the product.

The marketing of medical devices may not be inappropriate, and it may not convey an exaggerated or false image of the device or its effectiveness or use. Neither may the marketing imply that the product has properties or uses which the manufacturer has not specified for it.

More detailed provisions on the claims made in the advertising of devices are set out in Article 7 of the MD Regulation and Article 7 of the IVD Regulation. 

The manufacturer of the device and the product or trade name given by the manufacturer at the time of registration of the device shall be indicated in the marketing.

The marketing must also indicate that the device concerned is a CE-marked medical device. And where a certificate from a notified body is required for the device, the number of the notified body that issued the certificate shall also be indicated in connection with the marketing.

A product that is not a medical device shall not be claimed as such in the marketing.

More information: Marketing of medical devices

A distributor is an operator, other than the manufacturer or the importer, that makes a device available on the market, as manufacturers and importers of a device cannot also be its distributors.  A distributor only operates in the common European market area, and the name or the contact details of the distributor do not need to be included on the device or its packaging. 

The distribution of medical devices may occur directly to consumers, professional users or to another distributor in the supply chain (e.g., to retail and online stores, pharmacies or wholesalers) up until the device is first put into service.  The obligations do not apply to the distribution of used and second-hand devices. Another criterion for the definition of a distributor is the transfer of ownership, possession or any other right concerning the medical device either for payment or free of charge.  The transfer does not necessarily require the physical handover of the device. The definition of a distributor also covers distance and online sales.

Construction, leasing and finance service providers

Medical devices may be distributed as part of a construction project where the devices are included. The client of the construction project is the distributor of the devices that are distributed as part of the whole project upon the transfer of ownership, possession or other right.

Leasing of medical devices can be considered a form of distribution. Although the ownership of the device does not change during a leasing service, the right of use and possession are often transferred to the end user. Thus, the leasing service provider can be the distributor of the device. As there are many forms of leasing, the definition of a distributor may need to be examined on a case-by-case basis. 

In terms of subsequent contracts or changes concerning the leasing service provider, the device has already been used. Therefore, it is not being put into service for the first time and these actions are not considered distribution. Operators that offer purely credit or finance services in support of the activities of manufacturers or other economic operators are also not distributors.

Fulfilment service providers

Operators that purely carry out warehousing, packaging or tender management services are not considered distributors of medical devices. Their activities are not governed by EU regulations on medical devices because the ownership, possession and/or other rights concerning the device do not change. The internal logistics services of the organisation are also not considered distribution as it is defined in the EU regulations. If the ownership, possession or other right of the device is transferred during the service, the provider of the logistics service becomes a distributor.

Only distributors who are obliged to notify Fimea must register to Fimea’s CERE register. Distributors are obliged to notify Fimea if they make a medical device available in Finland to retailers, healthcare and social welfare operators and other professional users. You can find more information on the “Registrations” page.