Laboratory of the Institute for medicines and medical devices has been established in December 2020 trough realisation of the project of purchase of laboratory equipment which was financed from the Instrument for Pre-accession Assistance EU IPA II (2014‐2020) in the Negotiation Chapter 1 – Free movement of goods:

Modular Multipurpose Powder Diffraction System Pananalytical Empyrean 3 (X-ray diffraction spectrometry, XRD)
Benchtop Energy Dispersive X-Ray Fluorescence (EDXRF) Spectrometer for Elemental Analysis Malvern Panalytical Epsilon 4 (X-ray fluorescence spectrometry, XRF).

The Laboratory is equipped with highly specific and sensitive techniques that ensure the protection of the Montenegrin market and citizens from the presence of falsified and substandard medicinal products. Also, through the activities of the Laboratory, the Institute conducts scientific and research activities, especially considering the fact that the Institute is a teaching base of the University of Montenegro.

Institute is fully dedicated to preserving the integrity and traceability of medicines and medical devices on Montenegrin market which is by the establishment of the Laboratory protected even more.

With the purpose of ensuring the quality of work and to demonstrate competence for conducting laboratory activities, continuous efforts are made to improve and maintain the Laboratory’s quality system through the application of the requirements of the standard MEST EN ISO/IEC 17025:2018 – General requirements for the competence of testing and calibration laboratories. On May 16, 2024, the Laboratory of the Institute for Medicines and Medical Devices of Montenegro was awarded an accreditation certificate by the Accreditation Body of Montenegro, in accordance with the requirements of the standard MEST ISO/IEC 17025:2018 – General requirements for the competence of testing and calibration laboratories.

The Institute’s commitment to the continuous improvement of the Laboratory’s quality system is set out in the Laboratory Quality Policy