Free Montenegro medical device classification tool

What the Montenegro classifier checks

How are medical devices classified in Montenegro?

CInMED uses a risk-based framework. Possible classes include IVDs: Class A, Class B, Class C, Class D; Medical devices: Class I, Class Is, Class Im, Class Ir, Class IIa, Class IIb, Class III. In vitro diagnostic medical devices are a separate kind of medical device under čl. 16 of the Zakon o medicinskim sredstvima, and CInMED classifies them on the Regulation (EU) 2017/746 axis. The notice of 18.06.2025 states that 'other' IVDs classified under Directive 98/79/EC are classified as class A under Regulation (EU) 2017/746, and that the devices moving to a higher class move into 'A sterilna, B, C, D'; the register records classes A, B, C and D alongside the legacy values Lista A, Lista B, Ostala IVD and Samotestiranje. CInMED applies the requirements of Regulation (EU) 2017/746 to these devices without Montenegro being bound by it, and the legacy Directive 98/79/EC declarations of conformity are no longer accepted after 26.05.2022. The national class axis of the Zakon o medicinskim sredstvima, not a projection of the EU MDR. Čl. 16 recognises three kinds of medical device (general, in vitro diagnostic and active implantable); čl. 17(1) grades general and active implantable devices into classes I, IIa, IIb and III by risk and delegates the classification conditions to the Ministry; čl. 18 puts the classification in the hands of a notified or appointed body, except for Class I and 'other' in vitro diagnostic devices, which the manufacturer classifies itself, with disputes decided by the Ministry or the Agency. CInMED's register adds Is, Im and Ir, and records active implantable devices as a separate category (AIMD). A CE certificate or other foreign conformity document is recognised as an input under the Pravilnik o priznavanju inostranih isprava i CE znaka, but recognising it is not the same as being governed by the MDR: the device still has to be entered in the CInMED register before it may be placed on the Montenegrin market. The applicable class depends on the product's intended purpose, duration of use, invasiveness, active functions, implantability, sterility, software role, and other market-specific rules.

What information does the Montenegro classifier use?

Current CInMED requirements and class information from similar registered products. Your result includes an explanation and links to the official sources used.

Is the result an official CInMED classification decision?

No. The result is a preliminary estimate based on the product details you provide and the information available. Confirm the classification with the applicable authority or a qualified regulatory professional before filing.