CInMED joins the International Medical Devices Regulators Forum


The Institute for Medicines and Medical Devices of Montenegro (CInMED) is delighted to announce its new status as an affiliated member of the International Medical Devices Regulators Forum (IMDRF). This milestone holds exceptional importance for CInMED as the regulatory authority for medical devices in Montenegro. It promises to catalyse the ongoing development and enhancement of the regulatory framework, with far-reaching implications for Montenegro’s industry, global positioning, and European integration processes.


Only six months after the official invitation of the chairman of the IMDRF, Dr Andrzej Rys, for CInMED to become a member of the family of international regulators in the field of medical devices, Montenegro proudly stands out as the only country in the region that has achieved this notable success, despite not being a member of the European Union (EU).


During the 24th IMDRF meeting, which took place in Berlin last month, representatives from CInMED, MSc Mira Kontić, Deputy Managing Director, and Dr Uroš Labudović, Head of the Centre for Medical Devices, attended the event at the invitation of the European Commission. This provided an excellent opportunity to introduce CInMED as Montenegro’s competent regulatory body in this field and to present the CInMED’s perspective and advantages of Montenegro’s market. The official application for affiliate membership status within IMDRF was also submitted.


IMDRF is a renowned international organization that unites regulators and experts in the field of medical devices from various parts of the world. Its primary objective is to promote global harmonization of regulatory approaches for medical devices. Membership in IMDRF offers the opportunity to exchange knowledge, experiences, and best practices among member countries, fostering an environment that encourages innovation and guarantees the safety and efficacy of medical devices. It establishes a robust and unified regulatory framework to address the growing challenges in public health protection and patient safety.


The members of this international organization are the most influential European and world regulators, such as the drug agencies of the USA, Brazil, Canada, Great Britain, Japan, China, Australia, etc.

For CInMED, becoming an affiliated member of IMDRF is a recognition of the high standards of quality and professionalism upheld by the Montenegrin regulatory authority. This membership opens doors to broader collaboration with other regulatory bodies and experts worldwide, enabling access to the latest information and guidelines in the field of medical devices.


Access to global standards and guidelines for the development and placement of medical devices will strengthen the competitive positions of Montenegrin companies on the international market and contribute to the country’s economic growth.


Furthermore, membership in IMDRF represents a significant step toward achieving Montenegro’s goals for EU accession. This is because embracing globally harmonized standards and regulations in the field of medical devices is crucial for EU compliance, facilitating and expediting the EU accession process.


This step towards IMDRF membership represents a great honor and responsibility for CInMED, along with recognition for the organization’s past efforts and dedication.


The status achieved by CInMED through this process opens doors to numerous advantages within this organization. It is especially important to highlight access to opportunities for professional development, staying updated on the latest trends and innovations, and strengthening our position for EU membership. Achievements in the field of medical devices, including the introduction of highly sophisticated new technologies for treating the most complex diseases, are truly pushing the boundaries of conventional medicine. Therefore, we must broaden our horizons and be prepared for the future brought about by scientific and technological advancements, while implementing measures that ensure the highest standards of patient protection.


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