medical device, packing or instruction for use only if this does not impair the visibility and legibility of the mark of conformity. Article 19 A medical device intended for clinical trials and a custom made device on the market must be accompanied by a statement from the manufacturer or an authorised representative of the manufacturer on the special purpose of the medical device in accordance with this Law and the regulations adopted for its implementation. A medical device intended for display at business fairs, exhibitions, presentations, etc. does not have to fulfil the conditions prescribed by this Law and the regulations adopted for its implementation, provided that a warning is indicated in a visible place that this medical device is not in compliance with the essential requirements and that its trade or use is forbidden for any purpose until it is in conformity with the essential requirements. The information necessary for the safe use of a medical device for the intended purpose, which is accompany medical device on the market or use in the Republic of Serbia, must be in Serbian and written in an understandable manner that takes into account the knowledge of the potential user, except the packaging of the medical device for professional use in accordance with this Law. When other regulations requiring the placing of the mark of conformity are applied to the medical device, this mark is evidence that this medical device meets the prescribed conditions. If one or more regulations allow the manufacturer to choose which solution to apply during a transitional period, the mark of conformity shall indicate that this medical device meets the provisions of only those regulations applied by the manufacturer. In this case, the manufacturer is obliged to document the detailed data contained in these regulations in the information or instructions for use required by these regulations and accompanying the medical device. 7. Incorrectly placed mark of conformity Article 20 If the Ministry determines that the mark of conformity has been placed unjustifiably or not placed at all, the manufacturer or authorised representative of the manufacturer or importer of a medical device that is not registered under Article 79 of this Law shall take appropriate corrective measures without delay. If the manufacturer or the authorised representative of the manufacturer or importer fail to take appropriate corrective measures in the case referred to in paragraph 1 of this Article, the Ministry shall limit or prohibit the placing on the market of that medical device, or take measures for its withdrawal in accordance with Article 21 of this law.
medical device, packing or instruction for use only if this does not impair the visibility and legibility of the mark of conformity. Article 19 A medical device intended for clinical trials and a custom made device on the market must be accompanied by a statement from the manufacturer or an authorised representative of the manufacturer on the special purpose of the medical device in accordance with this Law and the regulations adopted for its implementation. A medical device intended for display at business fairs, exhibitions, presentations, etc. does not have to fulfil the conditions prescribed by this Law and the regulations adopted for its implementation, provided that a warning is indicated in a visible place that this medical device is not in compliance with the essential requirements and that its trade or use is forbidden for any purpose until it is in conformity with the essential requirements. The information necessary for the safe use of a medical device for the intended purpose, which is accompany medical device on the market or use in the Republic of Serbia, must be in Serbian and written in an understandable manner that takes into account the knowledge of the potential user, except the packaging of the medical device for professional use in accordance with this Law. When other regulations requiring the placing of the mark of conformity are applied to the medical device, this mark is evidence that this medical device meets the prescribed conditions. If one or more regulations allow the manufacturer to choose which solution to apply during a transitional period, the mark of conformity shall indicate that this medical device meets the provisions of only those regulations applied by the manufacturer. In this case, the manufacturer is obliged to document the detailed data contained in these regulations in the information or instructions for use required by these regulations and accompanying the medical device. 7. Incorrectly placed mark of conformity Article 20 If the Ministry determines that the mark of conformity has been placed unjustifiably or not placed at all, the manufacturer or authorised representative of the manufacturer or importer of a medical device that is not registered under Article 79 of this Law shall take appropriate corrective measures without delay. If the manufacturer or the authorised representative of the manufacturer or importer fail to take appropriate corrective measures in the case referred to in paragraph 1 of this Article, the Ministry shall limit or prohibit the placing on the market of that medical device, or take measures for its withdrawal in accordance with Article 21 of this law.
Zakon-o-medicinskim-sredstvima_ENG_-22-05-18.docx