The European Commission has issued a mandate, obliging all EU countries to use a European databank for medical devices (Eudamed) as of May 1, 2011.
Eudamed is a secure web-based portal for rapid information exchange between national authorities and is already used on a voluntary basis by a number of EU countries.
The Eudamed databank will boost market surveillance, as national authorities will be able to rapidly access safety data for medical devices on the EU market, and to respond to risks, for example, by ordering a withdrawal. The databank will also streamline the rules for manufacturers placing in vitro diagnostic devices on the market, according to the commission.
Under EU law, medical devices cover thousands of product types used in diagnostics, prevention and therapy. They range from life-supporting devices such as pacemakers, implants, complex diagnostic devices, such as x-ray scanners, to devices such as blood pressure meters, syringes or blood and urine tests.