Every medical device that is placed on the market shall be labelled with data for its safe and proper use. The packaging of the medical device shall contain the information on the manufacturer, the data necessary for the identification of the medical device and the content of the packaging, the necessary labels such as ,,sterility”, ,,single use”, ,,custom-made”, ,,for clinical investigation” and similar, identification code, expiry date, conditions of storage, special method of use, if required, warnings, intended purpose and other necessary data of importance for the protection of health. Data for the safe use of a medical device shall be indicated on the medical device itself and/or the packaging of each individual part, when feasible and appropriate, or on the sales package when appropriate. The instructions for use shall be placed in the packaging of each medical device.
Exceptionally, the instructions for use shall not be required for class I or IIa medical devices, in justified cases, for in vitro diagnostic medical devices, if they can be safely used without the instructions for use.
Instructions for use of a medical device shall be written in Montenegrin language and in languages that are in official use in Montenegro in accordance with the registration, and shall correspond in their entirety to the original text of the manufacturer’s instructions and be prepared in a way that is understandable to the patient and user. The manufacturer shall clearly state the intended purpose of the medical device on the packaging of the medical device and in the instructions for use.
If it is rational and feasible, the medical device and its constituent parts shall be labelled with the batch number, in order to enable all necessary measures in case potential risks of a medical device and its constituents are identified.
The inner and outer packaging of a medical device for professional use shall be labelled in Montenegrin language and in the languages that are in official use in Montenegro. Outer packaging of a medical device for professional use may be labelled in English, with a label containing all the information contained on the original packaging. The outer packaging of a medical device that the patient uses independently shall be labelled in Montenegrin language and in the languages that are in official use in Montenegro. Information on the manufacturer or the authorized representative of the manufacturer of the medical device and the number of the decision on registration of the medical device shall be stated on the outer packaging and may be indicated on the label that is placed on the outer packaging of the medical device.
Instructions and forms
Page is under construction.