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New Spanish law transposes EU medical devices legislation

This article was originally published in RAJ Devices

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.




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