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June 2016, European Food and Feed Law Review
January 3, 2017, Inside Medical Devices
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 … ...
November 28, 2016, Politico
Cándido García Molyneux and Bart Van Vooren are quoted in a Politico article regarding the recent European Court of Justice rulings which interpreted elements of a global chemical safety protocol. According to García Molyneux, “The EU Court’s rulings of this week are not that surprising in light of the [safety protocol] Aarhus Convention and the EU’s ...
September 9, 2016, Inside Medical Devices
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 ...