(Intertek: Boxborough, MA) -- Intertek, a leading global provider of quality and safety solutions, is working with medical device manufacturers who are currently under pressure to stay compliant under widespread changes to EU regulations. 

The European Union has published a revision to its medical device directive (MDD), which defines essential quality and safety requirements for all medical devices imported, sold, and used in the European Union.The changes, which become mandatory on March 21, 2010, represent the first significant revisions to the MDD in 15 years.Some of these changes—such as new requirements for devices containing phthalates, and an added connection to the machinery directive—are major departures from the status quo.

Many manufacturers are scrambling to effectively implement the new requirements before the March 2010 deadline. Most medical devices require the approval of a notified body before they can bear the CE mark. Part of this approval process is a technical file review, during which the notified body reviews the device's full construction details as provided by the manufacturer. However, notified body review times—three months or more are not uncommon—may threaten manufacturers' continued compliance.

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