New Requirements of EU Medical Device Directive Need Immediate Action, Nerac Analysts Urge in Newly Published W...( TOLLAND Conn. Dec. 3 /- Medical devic...),Health

TOLLAND, Conn., Dec. 3 /PRNewswire/ -- Medical device manufacturers should start initiating strategies now to comply with the new requirements of the amended European Union Medical Device Directive that take effect in March 2010, a newly released Nerac white paper urges.

"At stake is maintaining or increasing share in the growing $86 billion market that accounts for a significant percentage of most U.S. medical device companies' profits," write Nerac Medical Device Analysts Deborah Schenberger, Ph.D., and Marco Bafan in the paper titled, Clinical Literature Reviews: Changes in the European Union's Medical Device Directive Require Manufacturers to Take Immediate Steps to Comply. "With nearly 8,000 devices on the EU market, it is possible that a backlog of applications as the deadline approaches could bottleneck approvals, with serious implications for sales and profits."

The paper, which can be downloaded at http://www.nerac.com/nerac_insights.php?category=white_papers&id=143, notes that several key changes in the directive will have profound impacts on medical device companies:

-- Medical device manufacturers must demonstrate safety and efficacy before any device can be sold in any of the 27 EU member nations.

-- All Class II devices require approvals, meaning thousands of companies that may not have been required to submit clinical data to sell products in the EU now must do so.

-- If even one significant change has been made since CE approval was granted, the device must go through the approval process again.

-- If clinical data is missing in the application for an existing device, the product must be withdrawn from the market until compliance is established.

-- After receiving certification, companies will be required to conduct extensiv
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