EU's Eudamed to be Mandatory in 2011

A European Commission decision adopted recently will oblige all EU countries to use, as of May 2011, a European databank for medical devices (Eudamed). This secure web-based system is currently being used by several member states on a voluntary basis. Only the national competent authorities have access.

According to the European Commission website, the information stored in Eudamed will be:

• registration of manufacturers, authorized representatives and devices,
• data relating to certificates issued, modified, supplemented, suspended, withdrawn or refused,
• data obtained in accordance with the vigilance procedure and
• data on clinical investigations.

The Eudamed databank is a secure IT tool which will ensure rapid access to such data by market surveillance authorities. In the EU, medical and IVD devices of varying risk levels are certified by a Notified Body in one member country, and legally traded with the CE marking, within other EU member states. According to the EC April 19, 2010 press release, “Even though these devices are traded on the European single market, data which are key to their safety – such as conformity certificates, data on clinical investigations – are for the time being collected only at the national level.”

The databank will also streamline the rules for manufacturers placing in vitro diagnostic (IVD) devices on the market because it will remove the requirements to notify every country the IVD is placed.