German medical technology law in force:
This article was originally published in Clinica
Executive Summary
Germany's revised medical technology products law will come into force on June 30, following its passage through the upper house on June 8. The lower house passed the law in May (see Clinica No 1256, p 7). It was last revised five years ago, but needs to be updated in several areas, including in the way "home-brew" diagnostic tests are regulated: own tests are still allowed, but will be regulated in the same way as commercially-available tests. Elsewhere, date-expired but still-effective and safe products may be used in cases of emergency or during crises, as a pragmatic and money-saving measure.