This event features a discussion with Dr Olia Kanevskaia (Utrecht University) and Vittorio Franzese (University of Tübingen).
Dr. Olia Kanevskaia and Vittorio Franzese will present their ongoing research on the use of international standards in the global regulation of technology focusing on the field of medical devices as a case study.
The global regulation of medical devices requires navigating sensitive trade-offs between market access and safety, and intersects with regulatory domains in which national initiatives remain dominant, such as cybersecurity, data protection, and artificial intelligence, making it an interesting case study. Moreover, although global governance bodies such as the WTO and WHO emphasise the importance of harmonising medical device regulation, significant divergences continue to persist across jurisdictions and between developed and developing countries.
To assess these trends, the study examines the uptake of international, regional, and national standards in the medical device legislation and regulatory practices of the US, EU, both developed economies and major exporters of medical equipment, and India, a developing country and one of the largest importers. By identifying which standards these jurisdictions reference in their legal frameworks, the paper evaluates whether, and to what extent, an 'international standards effect' is producing regulatory convergence, or whether national and regional preferences continue to sustain fragmentation. In doing so, the paper offers an empirically grounded account of these dynamics and situates the analysis within the broader literature on technology regulation and global governance, providing a foundation for future research across multiple regulatory domains.
Speakers:
Dr. Olia Kanevskaia is assistant professor of International and European Economic Law and Technology at Utrecht University. She holds a PhD in international economic law from Tilburg University, and taught and conducted research before at KU Leuven, NYU Law School, and Stanford Law School. Her research focuses on different legal aspects of technical standardisation, and she has published broadly on the topic in recognised international outlets.
Vittorio Franzese is a PhD student at the CZS Chair for Law and Artificial Intelligence at the University of Tübingen. He holds a master's degree in law from the University of Naples Federico II. His research focuses on the intersection of law and technology, with particular emphasis on AI regulatory frameworks and technical standards. He also serves as an external expert at the University of Bari for the 'Self-Assessment Network Impact Program' research project.
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