Press Release: Patient safety: EU-wide databank for medical devices to boost market surveillance

A European Commission decision adopted on 19 April 2010 will oblige all EU countries to use, as of May 2011, a European databank for medical devices (Eudamed). Medical devices range from life-supporting devices such as pacemakers through hip implants or X-ray machines, down to products used daily such as syringes or blood tests. 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 Eudamed databank is a secure IT tool which will ensure rapid access to such data by market surveillance authorities. The databank will also streamline the rules for manufacturers placing in vitro diagnostic (IVD) devices on the market.