ADVERTISING FOR MEDICAL DEVICES AND PLACING THEM ON THE MARKET – GENERAL RULES

In accordance with the legislation applicable in Romania, advertising regarding medical devices does not have to contain any special mention (disclaimer), which is only mandatory for pharmaceuticals and dietary supplements.

Directive 93/42 / EEC of 14 June 1993 concerning medical devices, transposed into national legislation by Decision no. 54 from 29 January 2009 of the Romanian Parliament, regarding the conditions for placing medical devices on the market, provides that a medical device “means any instrument, apparatus, appliance, software, material, or other article, whether used alone or in combination, including the software necessary for its proper application, intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:

– diagnosis, prevention, monitoring, treatment or alleviation of disease;

– diagnosis, monitoring, treatment, alleviation or compensation for an injury or handicap;

– investigation, replacement or modification of the anatomy or of a physiological process;

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

Medical devices form a huge range of products, from everyday items like house-hold appliances, such as adhesive bandages, contact lenses and pregnancy tests, to materials such as dental fillings, X-ray machines, pacemakers, breast implants, hip prostheses and blood tests for HIV / AIDS. Around 500 000 different types of devices exist on the market. They are classified into different risk classes: Class I (low risk), class IIa (low to medium risk), Class IIb (medium to high risk) and Class III (high risk).

One can easily see that medical devices should not be considered pharmaceuticals. The difference between them has an impact on the applicable advertising rules.

The distinction between medical devices and pharmaceuticals was underlined by the European Commission in a note issued on 26.09.2012: “Medical devices should not be confused with medication (often referred to as pharmaceuticals), these being the subject of a different regulation framework. The main difference between medical devices and medication refers to the main mean of action of the product, usually of physical nature in case of a medical device (e.g. mechanical action, physical barrier, replacement or sustaining of organs or physiological functions …) “.

Thus, in the event of commercial communications, it is mandatory that advertising regarding pharmaceuticals contains the following warning: “This product can be obtained without prescription. We recommend you to carefully read the prospectus or information on the packaging. If unpleasant manifestations occur, contact your doctor or pharmacist“.

We mention that this statement does not need to be mentioned in advertising regarding medical devices.

Medical devices are not governed by marketing rules as strict as those concerning pharmaceuticals. A declaration of conformity from the manufacturer shall suffice.

For example, Class I medical devices will be subject to the provisions of art. 11 para. (5) of Directive 93/42 / EEC of 14 June 1993 concerning medical devices: “In the case of devices falling within Class I, other than devices which are custom-made or intended for clinical investigations, the manufacturer shall, in order to affix the CE marketing, follow the procedure referred to in Annex VII and draw up the EC declaration of conformity required before placing the device on the market“.

The procedure mentioned in Annex VII of Directive 93/42 / EEC of 14 June 1993 refers to the declaration of conformity through which the manufacturer or his authorized representative established within the Community, ensures and declares that its products meet the requirements of the Directive.

We however stress the fact that, although market-placing and advertising of medical devices benefit from legal provisions less complex than in the case of pharmaceuticals, no manufacturer or distributor of such products must mislead the consumer or inform him wrongly.

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