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October 6, 2025


Classification of in-vitro diagnostic medical devices: how to avoid a too-high classification

By Dr. Juliane HavlicekOctober 6, 2025Leave a comment

The classification of in-vitro diagnostics (IVD) can have far-reaching consequences, as it has an impact on the conformity assessment procedure, certification audits, and, thus, on market launch. To help you prevent the unnecessary allocation of your IVD product to a high-risk class, this article provides an overview of

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

By Dr. Juliane HavlicekOctober 6, 20252 Comments

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 connection between intended purpose and intended use make it difficult to achieve clarity and precision. This article reveals how to…

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