• Sven Jungmann

In Vitro Diagnostic (IVD) medical device

First off, let’s define, “in vitro.” This term refers to where a process takes place: in a culture dish; a test tube (e.g., in-vitro fertilization); or anywhere outside of the human body.

Thus, an in vitro diagnostic medical device refers to a device intended to be involved in the examination of tissue/living specimens and performs this task outside of the human body. These devices can include:

  • reagents

  • calibrators

  • control materials

  • specimen receptacles

  • software

  • related instruments

The purpose of this device is to provide information or aid in diagnosing, screening, monitoring, and predicting.

Source: http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-131209-samd-key-definitions-140901.pdf



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