From May 2011, a single, common database for the registration of medical devices will be in force in the EU. For manufacturers of in vitro diagnostic devices, this will mean one registration at the EU level, and not – as before – separately in each country.
The decision was announced by the European Commission on Monday.
In the European electronic register of medical devices Eudamed, where registrations are now voluntary, you can find all the products needed in medicine – from x-rays and pacemakers to the most common pressure measuring devices and syringes. Currently, all information necessary for their registration is collected at the national level. It goes, among others o various types of certificates or test results or reports on accidents caused by the use of a given product. From next year, this information will have to be entered into the European database.
Today’s decision by the European Commission is good news for all patients in the EU. Their security will increase because national offices will have quick access to the most important data about products, said Health Commissioner John Dalli on Monday.
The EC also argues that a common database will make life easier for producers. For example, it is enough for manufacturers of in vitro diagnostic devices to submit their product in one EU country to obtain the right to market it throughout the EU through Eudamed, the European Commission reported.
According to the EC data, in 2009 there were 600 accidents involving medical devices in the EU. The EC hopes that the safety of the products placed on the market will increase after the introduction of a mandatory register at the European level. National inspection authorities will be able to react immediately when a product fails in another member state – for example by withdrawing it from its market.
Karolina Przewrocka (PAP)