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EU to Adopt Medical Device Database

by Brendon Nafziger, DOTmed News Associate Editor | April 22, 2010
European Union
In an effort to improve public safety, the European Union will adopt a pan-Europe online database for medical device products by next year, the EU's executive body announced this week.

The European Commission has decided to require all member countries to use Eudamed, a Web-based portal for documenting a range of medical device products, by May 2011.

The secure database will allow countries to rapidly share critical safety information on medical devices, the EU says. Currently, while EU-approved devices can be sold throughout the EU economic zone, data on safety and malfunctioning or adverse incidents involving medical devices are only collected nationally.

According to the EU, there were 600 incidents involving medical devices last year.

"Today's decision means good news for patients across the EU. It will lead to increased patients' safety thanks to rapid access to critical data by national authorities," said the European Commission's health and consumer policy expert John Dalli in a statement.

The commission's decision applies to a broad range of medical devices, from pacemakers and X-ray machines to syringes and blood and urine tests.

The EU expects the changes to ease some regulatory burdens, at least on makers of in vitro diagnostic products. Now, sellers of these devices must separately inform each EU country they plan to sell their products in, but the new decision will streamline that, according to the European Commission's Web site.