Spain transposes EU blood products directive:
This article was originally published in Clinica
Executive Summary
Spain has transposed EU legislation that regulates medical products containing stable products from human blood or plasma. Royal Decree 710/2002 replaces Royal Decree 414/1996, after the EU amended directive 2000/70/CE with directive 2001/104/CE due to a translation error that exempted products derived from blood and plasma from the medical device regulations (see Clinica No 992, p 3). The new decree, which was approved on July 19, over a month after its due transposition date, will be enforced gradually: products regulated by it may be sold only until December 13 2005 and must be used before December 13 2007.