Pursuant to Article 9 item 51 of the Law on Medical Devices a manufacturer of a medical device is a legal or natural person responsible for its design, manufacture, packaging and labelling before placing it on the market under his own name, regardless of whether these activities have been carried out independently, or by another person on his behalf.
Therefore, a manufacturer is a person who independently or through contract manufacture produces a medical device, places it on the market under his own name and owns all the rights and obligations regarding the manufacture of products from his product range.
Thus, in accordance with the applicable regulations, the registration procedure for manufacturers that do not have their headquarters/residence in Montenegro has been amended, and therefore it cannot be considered that a natural or legal person manufacturing medical devices under his own name is a manufacturing site of a certain manufacturer, but a manufacturer.
The situation where one person that is a manufacturer operates under another person or corporation, as well as their corporate relations, are not relevant for the registration procedure in terms of the above-mentioned legal definition of a producer and the difference in relation to the manufacturing site.
In relation with the aforementioned, please be reminded that Article 140 of the Law on Medical Devices (“Official Gazette of Montenegro”, No. 24/19) defines that legal persons that manufacture medical devices and carry out wholesale and retail sale of medical devices are obliged to harmonize their operation and activities with this Law, within 24 months from the date of coming into force of this Law.
In accordance with the provisions of the Law on Medical Devices, registration holders are obliged to submit an application for amendment of the previously issued decisions, i.e., harmonization with the Law on Medical Devices, so that all stated manufacturing sites from the decisions that have the properties referred to in Article 9 item 51 of the Law on medical devices would be registered as manufacturers, in accordance with the Law into which the applicable European regulations have been transposed; mentioned regulations give the manufacturer all the rights when deciding about, i.e., choosing his own authorized representative for a certain territory.
Bearing in mind that the transitional period for harmonization referred to in Article 140 of the Law on Medical Devices has expired and that there are a certain number of non-compliant decisions on the registration of manufacturers that do not have their headquarters/residence in Montenegro, the Institute for Medicines and Medical Devices has decided to extend the deadline. In that sense, it is necessary to harmonize the decisions on the registration of manufacturers that do not have their headquarters/residence in Montenegro (by submitting an application for registration, i.e., an application for amendment to the registration) within 3 months from the date of delivery of this notification and no later than February 06, 2024.
Also, please note that in case that necessary harmonization of the mentioned decision is not carried out, the Institute will ex officio initiate the procedure of removing the manufacturer, in accordance with Article 59 paragraph 1 item 2 of the Law on Medical Devices.
The Institute for Medicines and Medical Devices is at your disposal for further cooperation.
