Regulatory Focus™ > News Articles > Overview of EU Medical Devices Directives Updates

Overview of EU Medical Devices Directives Updates

Posted 01 September 2010

The European Commission is required to periodically review the Medical Devices Directives (MDD). As a result of a recent review, the Commission issued Directive 2007/47/EC of 5 September 2007, which specifies amendments to the MDD and other directives. The current MDD amendment was constructed from a multitude of submissions and comments received by the Commission from industry, trade associations, national authorities and other stakeholders. The main changes were editorial-to provide clarification and remove inconsistencies. To further strengthen EU regulations, the European Database on Medical Devices (eudamed) will go into effect in May 2011. The European Commission is also considering completely renovating the current directives and possibly simplifying and combining some directives into one. This article focuses on the changes made to the MDD.


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