End to EU notifications in sight for IVD manufacturers as Eudamed becomes mandatory

 

13 May 2010


The obligation on IVD manufacturers to give notification to every EU Member State concerned by the placing on the market of devices will cease to apply as of May 2011. This is happening because the provision in Article 10 of Directive 98/79/EC is a transitional provision that is only in place until the use of Eudamed becomes mandatory.  

Eudamed is the European databank of medical devices and contains data on registration of manufacturers, authorised representatives and devices; certificates; clinical investigations; and data obtained in accordance with vigilance procedure. The databank is intended to provide Member State competent authorities with fast access to the information via a secure web-based portal, thus supporting market surveillance and transparency. In April 2010 the European Commission decided that use of Eudamed, currently used voluntarily by several Member States, would be mandatory as of 1st May 2011.

 

More info on Eudamed

 


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