European Health Data Space EHDS: An overview for medical device and IVD manufacturers

Regulation (EU) 2025/327 on the European Health Data Space (EHDS for short) is another European regulation that may affect medical device and IVD manufacturers. This article explains what this regulation requires and what these manufacturers have to do by when, as well as the possible advantages of the EHDS and the EHDS Regulation.

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Intended purpose and intended use: More consequences than you think!

The correct and precise formulation of the intended purpose of medical devices and in vitro diagnostic medical devices (IVD) is crucial for their successful development and approval. However, even the definitions of terms and the distinction between intended purpose and intended use make it difficult to achieve clarity and precision. This article reveals how to…

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