Medical devices play a key role in saving lives by providing innovative health solutions for diagnosis, prevention, monitoring, prognosis, treatment and mitigation of a wide range of diseases.

By harmonizing national regulatory framework with the European, the Institute for medicines and medical devices ensures smooth functioning of internal market, based on a high level of health protection for patients and users. Examples of medical devices are as follows: patches, contact lenses, X-ray machines, pacemakers, breast implants, software applications, HIV blood tests, pregnancy tests, blood sugar monitoring systems for diabetics, etc. 

Institute performs registration of a medical device for which the conformity assessment was carried out and which is placed on the market, i.e. put into service by entering into the register of medical devices. 

Person submitting an application for registration of a medical device may be:

• the manufacturer of a medical device established in Montenegro, or its authorized representative;
• for the manufacturer of a medical device not established in Montenegro, its authorized representative, which is established in Montenegro.

An application for registration of a medical device may be submitted by a natural or legal person
with a seat or residence in Montenegro for one medical device.