Information for distributors of medical devices
Medical devices are regulated by both national laws and the EU legislation. The Finnish Medicines Agency (Fimea) is the competent supervisory authority for medical devices.
The ‘Distributors’ section contains information about:
- the requirements for medical devices:
- the proper marketing of devices;
- the notification of adverse incidents; and
- the distributor’s checklist.
What is a medical device?
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.
Conformity and CE marking
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.
Export of devices from outside the EU
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 Articles also specify claims that are forbidden. In addition, the marketing of IVD devices is regulated by section 11 of Act 629/2010.
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.