Legal Acts in English

This Law shall regulate the conditions for the manufacturing and marketing of medical devices, i.e. their placing on the market and use in the Republic of Serbia, clinical investigation of medical devices, vigilance, monitoring of medical devices on the market and technical assessment, assessment of the compliance of medical devices with essential requirements, advertising, the labelling of medical devices and supervision in this field, as well as other issues of relevance to medical devices.

The provisions of this Law shall apply to medical devices for human use (hereinafter: medical devices), including in vitro diagnostic medical devices and active implantable medical devices.

The provisions of this Law relating to the manufacturer of medical devices shall also apply to legal and natural persons who compile the system or set, pack, make, completely renew and label one or more finished products and determine the purpose of the medical device for placing on the market of the Republic of Serbia under its own name. The provisions of this Law shall not apply to a person who, although not a manufacturer, compiles or adjusts a medical device for a specific purpose, already on the market and intended for a particular user.

The provisions of this Law shall also apply to accessory for a medical device (accessory).

The provisions of this Law shall apply to a medical device intended for the administration of a medicinal product in accordance with the law governing medicinal products, without prejudice to the provisions of the law governing medicinal products. If this medical device is placed on the market so as to make an integral product with the medicinal product intended exclusively for use in a given combination and which cannot be reused, the provisions of the law governing medicinal products shall apply to that product. The provisions of this Law shall apply to the essential requirements regarding the safety and performance of this medical device, as well as shall the regulations adopted for its implementation.

The provisions of this Law shall apply to a medical device that has a substance as an integral part which, if used separately, can be considered as a medicinal product in accordance with the law governing medicinal products and that have an action ancillary to that of the medical device.

When deciding whether the law governing medicines shall apply to a product or this Law, special attention shall be paid to the main (primary) mode of action of the product.

The provisions of this Law shall apply to a medical device that has a substance as an integral part which, if used separately, may be considered a medicinal product consisting of human blood or human plasma or a medicinal product derived from human blood or human plasma, in accordance with the law which regulates medicinal products and which could have an effect on a human body that is ancillary to the action of a medical device (hereinafter: a human blood derivative).

The provisions of this Law shall apply to certain groups of products that the manufacturer has intended only to aesthetic or other non-medical purposes, but which are similar to the medical devices in terms of functioning and risk profile. Products that have a medical and non-medical purpose must also comply with the provisions of the law applicable to that type of products which are not intended for medical purposes.

This Law shall not apply to:

1)                  Medicinal products;

2)                  Cosmetic products;

3)                  Human blood, blood products, plasma or blood cells of human origin or products containing such blood products, plasma or cells at the time of placing on the market, other than the product referred to in paragraph 8 of this Article;

4)                  Grafts, tissues or cells of human origin or derivatives thereof, nor on products containing or consisting of them, unless the medical device is manufactured by using tissue derivatives or cells of human origin which are non-viable or are rendered non-viable, as well as products from paragraph 8 of this Article;

5)                  Grafts, tissues or cells of animal origin or their derivatives or products containing or consisting of them, unless the medical device is manufactured by using tissues or cells of animal origin or derivatives thereof, which are non-viable or are rendered non-viable;

6)                  Medical device for use solely in veterinary medicine.