On the behalf of the submitter the Bill was presented by Meho Mahmutovic, State Secretary at the Ministry of Health, who said that the reason behind the Bill is rapprochement with EU directives and other regulations concerning medical devices relating to the directive for medicinal devices for human use, directive for active implantable medical devices, in vitro diagnostic medical devices, guidelines and guides. The Secretary said that the Law on Medicines and Medical Devices begun the process of rapprochement with EU regulations in these areas. The area of medical devices has been partially harmonized with the abovementioned EU directives so that the economy, which at the time was not operating within EU standards, could continue its operation on the territory of the Republic of Serbia. During the time this Law was in force almost all the entrepreneurs adjusted their business dealings with the abovementioned EU directives making it possible to fully adjust the Serbian regulations in the area of medical devices with EU legislation.

Following the presentation the Committee unanimously accepted the Bill on Medical Devices.

The sitting was chaired by Committee Deputy Chairperson Elvira Kovacs, and attended by the following Committee members and deputy members: Vladimir Djuric, Zvonimir Djokic, Dr Muamer Bacevac, Dusica Stojkovic, Gordana Comic, Dragan Sormaz, Krsto Janjusevic, Milimir Vujadinovic, Vesna Markovic and Dubravka Filipovski.