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BioTalk

2 results for: mdr

7/27/2026 8:51:31 AM

Is Your Healthcare AI Tool a Medical Device? What the CJEU's Latest MDR Decision Means for Digital Health Companies

By Christian Lindenthal Clarissa Junge-Gierse Annelie Säurig

The Court of Justice of the European Union (CJEU, 2 July 2026, Case C-427/24, Diagramm Halbach) has recently issued an important judgment...

9/4/2025 4:43:11 PM

By Henri Kaikkonen

As digital health applications become increasingly sophisticated and telemedicine (the distribution of health-related information and...