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Navigating the New EU Rules for Medical Device Software

This article was originally published in SRA

Executive Summary

Directive 2007/47/EC marks the introduction in the European Union of stricter rules for software used with medical devices1. The directive, which is set to come into force on 21 March 2010, will require for the first time that certain software be classified as medical devices and validated and CE-marked accordingly. The new rules are incorporated in the directive in the form of amendments to the existing directive on medical devices2 (the MDD) and the current directive on active implantable medical devices3 (the AIMDD).

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