Medical devices

What is the scope of the Act on Medical Devices?

The purpose of the Medical Devices Act is to regulate the trade in medical devices and, by doing so, to guarantee the safety, suitability and performance levels of medical devices as well to ensure adequate health protection of patients, users and other persons.

Medical devices are all instruments, apparatus, appliances, substances or preparations made from substances or other articles, used alone or in combination, including the software necessary for the medical device's proper application intended by the manufacturer to be used for human beings, by virtue of their functions, among others for the purpose of diagnosis, prevention, monitoring, treatment or alleviation of disease (§ 3 of the Medical Devices Act).

The Medical Devices Act contains prohibitions the purpose of which is to ensure protection of patients, users and other persons, prerequisites for placing medical devices on the market and putting them into service, definition of responsibilities of competent authorities as well as fining provisions.

What role does the Food and Commodity Goods Law or the Law on Advertising in the Healthcare System play?

As far as communication (advertising, package, etc.) is concerned, articles of food, especially dietary supplements are often advertised „in a boundary area“, namely by means of statements which could rather be attributed to medicines. The latter would, however, significantly reduce the marketability of such products, and could moreover lead to the application of the Law on Advertising in the Healthcare System.

According to § 2 (3) Nr. 1 of the Pharmaceutical Act and § 1 of the Food and Commodity Goods Law, the question has to be answered first if we are concerned here with an article of food as defined by of § 1 of the Food and Commodity Goods Law. This law defines articles of food as substances which are intended to be consumed by human beings, which excludes substances which are consumed „predominantly“ for purposes other than nourishment or pleasure. Considering the purpose of a substance and its actual role on the market, the possible ways it can be used are decisive as objective characteristics. Thus, dietary supplements can be regarded to be articles of food, only if their consumption can be put down to nutrition grounds, i.e. if insufficient nutrition leads to consuming such dietary supplements.

What do we need to handle your legal question relating to the Medical Devices Act?

Due to the complex nature of the abovementioned area of law, we cannot state in general what information and documents we need in order to handle your legal question. Please contact us for details.