Law on Medical Devices presented

On 28 February 2018, the Ministry of Health presented the new Law on medical devices ("Off. Gazette of the Republic of Serbia", No. 105/2017) at the Serbian Chamber of Commerce. The law was passed on 1 December, 2017 and will start to apply as of 02 December 2018.

Representatives of the Ministry of Economy, Medicines and Medical Devices Agency of Serbia and the Accreditation Body of Serbia took part in presenting the Law. The competencies of the Accreditation Body of Serbia according to the Law on Medical Devices were presented by Radivoje Nikoličić, Assistant Director of Development and Quality. You can see the presentation here.

There were more than 200 representatives of manufacturers/authorised representatives of manufacturers and other parties interested in placing on the market and use of medical devices in the Republic of Serbia at the presentation of the law.

The Law regulates the conditions for the production and sale of medical devices, ie their placing on the market and use in the Republic of Serbia, clinical testing of medical devices, vigilance, monitoring of medical devices on the market and technical evaluation, conformity assessment of medical devices with basic requirements, advertising, labeling medical devices and surveillance in this area, as well as other issues of relevance to medical devices.

The new law transposed the solutions, applied to the conditions in the Republic of Serbia, which are prescribed in the European Union in the directives and regulations relating to medical devices.

The competencies of the Accreditation Body of Serbia according to the Law on Medical Devices are regulated in Articles 12, 15, 16, 26 and 101, which stipulate that the assessment of conformity of medical devices with crucial - essential requirements, which will be prescribed by the Minister of Health on the basis of the new Law, is performed by designated and authorized bodies, which must previously be accredited for the conformity assessment activities by the Accreditation Body of Serbia. The designated bodies will assess the conformity of medical devices before placing them on the market, for the account of the manufacturer, and the authorised bodies will assess the conformity of medical devices during their use – life cycle, for the account of the Ministry of Health.