New Spanish law transposes EU medical devices legislation
This article was originally published in SRA
Executive Summary
Spanish medical device legislation that transposes into national law European Union Directive 2007/47/EC, the so-called amending directive, will enter into force on 21 March, the same day the provisions of the directive come fully into play1,2. The legislation, RD 1591/2009, repeals the previous Spanish law governing medical devices, RD 414/963; RD 414/96 had transposed the directive being amended (Directive 93/42/EEC) and introduced some additional country-specific measures that will continue or be updated under the new law.