Classification of in-vitro diagnostic medical devices: how to avoid a too-high classification
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 ensure that your IVD product is not unnecessarily allocated to a high-risk class, this article provides an overview of 1. What qualifies a product as an IVD?…
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