This article was originally posted on our sister blog 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 interpreted, this post looks at two recent judgments pertaining to medicinal products before the EU Court of Justice: Joined Cases C-544/13 and C-545/13 Abcur (link here) and Case C-276/15 Hecht-Pharma (link here). Although there are evidently major differences between the medical device and medicines regulatory regimes, these judgments nevertheless provide useful guidance to interpret the notion “(non-)industrial scale” under the draft MD Regulation.
Continue Reading EU Medical Devices Regulation Series: Interpreting the “Industrial Scale” Concept