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Tag Archives: In Vitro Diagnostic Medical Devices Directive

EUROPEAN COMMISSION REVISES BLUE GUIDE ON THE IMPLEMENTATION OF EU PRODUCT RULES

The European Commission has published a revised Blue Guide on the implementation of European Union product rules (“Blue Guide”).  The Blue Guide aims to facilitate an improved understanding of the European Union (“EU”) legal framework for the placing of various products on the EU market and to ensure its uniform and coherent application across the

European Parliament plenary vote on revised medical devices package

On 22 October 2013, the European Parliament voted, during a plenary session, on two draft Regulations intended to replace the current Medical Devices Directive[1], the Active Implantable Medical Devices Directive[2], and the In Vitro Diagnostic Medical Devices Directive[3]. The draft Regulations[4] will now be discussed by the Council of the European Union (“Council”) which is