Software and artificial intelligence are increasingly central to modern healthcare technologies. At the same time, the Medical Device Regulation, In Vitro Diagnostic Regulation, and the EU Artificial Intelligence Act introduce specific regulatory requirements for the development, validation, and commercialization of these solutions.
Understanding these requirements early is essential for successful development and market access.
The European regulatory framework for medical devices and in vitro diagnostics has undergone significant changes with the implementation of the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).
These changes directly affect research institutions, startups, and innovation teams developing new healthcare technologies and preparing them for market entry.
Last October, Rīga Stradiņš University published the book Psycho-Oncology, written by Asst. Prof. Dr. med. Velga Sudraba and lecturer Jana Duhovska.
Photo: Courtesy of Maija Radziņa
The European Union – European Cancer Screening and Early Detection Policy Summit was held in Brussels on 17-18 February 2026, bringing together European health policymakers, researchers, and industry experts to strengthen cooperation in cancer screening and early detection across Europe.
