Bart Van Vooren

Bart Van Vooren

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EU Medical Devices Regulation Series: Interpreting the “Industrial Scale” Concept

The term “industrial scale” appears twice in the draft EU Medical Devices Regulation (“MD Regulation”) in relation to so-called “in-house devices.” The term equally appears in the draft in-vitro diagnostic medical devices (“IVD”) Regulation. To provide perspective on the meaning of “industrial scale” and how the draft MD Regulation’s use of the term may be … Continue Reading

Is Medical Software a Medical Device? European Court of Justice to Decide

On June 13, 2016, the French Conseil d’État (supreme administrative court) referred to the EU Court of Justice (“CJEU”), the question of whether medical software that provides support to healthcare professionals in prescribing medicinal products should be considered a medical device under Directive 93/42 (the “Directive”) (Case C-329/16).  The qualification of software as a medical … Continue Reading