Bucharest, 4–6 June 2026

Romania has researchers, clinicians and engineers capable of developing cutting-edge medical technologies. But the road from prototype to a certified device available to patients remains long and costly. One of the missing links is the assessment and certification infrastructure. This problem and its solutions were discussed at MedFEST 2026, where ROHEALTH – The Health and Bioeconomy Cluster was present both in the clinical trials panel and with a stand in the exhibition area.

About MedFEST

Now in its third edition, MedFEST is organised by the National University of Science and Technology POLITEHNICA Bucharest (UNSTPB), in partnership with the “Carol Davila” University of Medicine and Pharmacy of Bucharest (UMFCD). The event took place on the Politehnica campus. It brought together doctors, engineers, researchers, companies and students, and one day was also open to the general public. MedFEST is thus one of the few spaces in Romania where medicine, medical engineering and industry talk directly, at the same table.

The clinical trials panel: positive signals for the ecosystem

The clinical trials panel discussed two main topics:

• the positive development of clinical trials in Romania;
• the infrastructure needed to facilitate technology transfer in the field of medical devices.

A key moment of the discussion was the confirmation from the President of the National Agency for Medicines and Medical Devices of Romania (ANMDMR), Mr Răzvan Mihai Prisada, of the need to develop a Notified Body in Romania. This direction also received the support of the President of the National Research Authority, Mr Andrei Alexandru.

Why does this matter? Notified bodies are the independent institutions that assess whether medical devices comply with European requirements and issue the certificates needed for CE marking. A notified body in Romania would mean faster and less costly access to certification for Romanian manufacturers, especially start-ups and SMEs. It would also considerably strengthen the national health innovation ecosystem. This is a strategic direction that ROHEALTH has long supported.

NoBoCap: more than 700 professionals trained across Europe

In her intervention, Flaviana Rotaru, President of ROHEALTH, presented the results of the European project NoBoCap (Notified Body Increased Capacity), funded under the EU4Health programme. The project had impact in two directions.

On the one hand, more than 700 representatives of economic operators from across Europe were trained in preparing technical documentation and in the regulatory requirements for placing medical devices on the market.

On the other hand, the project helped train specialists within notified bodies. They gained advanced skills in assessing and certifying medical devices that integrate artificial intelligence technologies, in line with the new European regulatory and safety requirements.

Flaviana Rotaru also stressed the need for predictable public funding for research. A competitive health innovation ecosystem depends on highly qualified people, and this is essential for Romania’s ability to develop advanced medical technologies.

At the ROHEALTH stand: dialogue with the next generation

ROHEALTH’s stand in the exhibition area was an opportunity to reconnect with partners, cluster members and collaborators. It also allowed direct dialogue with those who will build the future of health research and innovation in Romania: students, young researchers and future professionals in the sector.

We talked about the importance of collaboration between research, industry, academia and public administration. We also discussed the opportunities offered by a sector in constant transformation.

Acknowledgements

We thank the organisers, the “Carol Davila” University of Medicine and Pharmacy of Bucharest and the National University of Science and Technology POLITEHNICA Bucharest. We are grateful for the opportunity to take part, for the excellent collaboration and for promoting debate topics that are relevant to the future of health, research and innovation in Romania.

We thank everyone who visited the ROHEALTH stand and contributed to these valuable conversations! See you at our next events.