The European Commission adopted a Decision on April 19, 2010, that will oblige EU Member States to use the European Database on Medical Devices (Eudamed) to record vigilance and clinical investigation information and to make it accessible by all competent authorities in all EU countries by May 1, 2011 (Commission Decision 2010/227/EU of 19 April 2010 on the European Databank on Medical Devices (Eudamed), OJ 2010 L102/45).
The Decision applies to devices covered by all three EU medical devices directives: the active implantable medical devices directive (AIMDD), the medical devices directive (MDD) and the in vitro diagnostic devices directive (IVDD).
Vigilance and Clinical Investigation Data Only
Even though the EU medical devices directives provide for a CE mark that allows the devices to be traded on the European single market, vigilance data (such as data on clinical investigations; data on conformity certificates, including those withdrawn or refused, on clinical investigations; or reports on malfunctioning or incidents) are for the time being collected only at the national level. As a result, vigilance data was only shared manually and on an incidental basis. According to the Commission, this comprises reports on 600 known incidents involving medical devices in 2009.
The EU has been working on developing a database accessible by all EU countries’ authorities that provides access to such data centrally for years. A number of EU countries has been experimenting with the database for some time, but its use was not mandatory.
Eudamed is a secure, web-based portal based on XML using codes from the EN 15225:2000 (Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange) standard to remedy translation problems. The information that will be included in the database is set out in the following table.
Data existing before May 1, 2011, in the EU countries’ authorities databases is included in Eudamed only insofar as necessary for the future functioning of Eudamed. This concerns existing data with respect to the registration of manufacturers, authorized representatives and devices. EU countries must have entered that data on April 30, 2012, at the latest.
The Eudamed databank will boost market surveillance, as national authorities will be able to rapidly access crucial safety data for medical devices on the EU market from all authorities in the EU. They will be able to respond to risks faster — for example, by ordering a withdrawal. Medical devices companies must now take into account that a vigilance report in one EU country will immediately be available to all authorities concerned with medical devices in the EU.
Manufacturers should note that the Eudamed database only concerns vigilance and clinical investigation data, which means that the manufacturers are not relieved from the obligation to register medical devices nationally when they are put on the market in an EU country, as EU countries may require under the medical devices directives. This will, however, change for in vitro diagnostic devices.
Streamlined Access for IVDs
The Eudamed databank will streamline the rules for manufacturers placing in vitro diagnostic (IVD) devices on the market by eliminating administrative hurdles for manufacturers of IVD devices. At present, they must notify every EU country concerned separately when placing certain IVD devices on the market. Eudamed will allow streamlined registration by enabling entry of the notification in Eudamed.