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New Requirements of EU Medical Device Directive Need Immediate Action, Nerac Analysts Urge in Newly Published White Paper

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, 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-- If clinical data is missing in the application for an existing device, the product must be withdrawn from the market until compliance is established.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 extensive post-market surveillance as part of their vigilance system.

Among the most important changes, the paper points out, is one that defines what clinical data can be used to demonstrate safety and performance. Clinical trial testing is one option, though it requires a lengthy, expensive process. An alternative is a clinical literature review of published data for similar devices. In fact, conducting the literature review should be the first step to discovering whether an appropriate comparison can be made or whether the company needs to engage in a more expensive meta-analysis or an even more costly, time-consuming clinical trial.

Dr. Schenberger (, who brings nearly two decades of industry and academic insight and experience to helping medical device companies achieve product approval through FDA, ISO and CE registration processes, has successfully submitted multiple medical devices to Notified Bodies for approval. She also has written numerous clinical literature reviews on behalf of Nerac clients, and all her reviews were approved by the clients' Notified Bodies. Mr. Bafan (, who has an academic background in biomedical engineering and a professional background as a business development and operations manager, is experienced in business strategy and hands-on research specific to the commercial biomedical and medical device industries.

About Nerac

Nerac Inc. ( is a global research and advisory firm for companies developing innovative products and technologies. Nerac Analysts deliver custom assessments of product and technology development opportunities, competitor intelligence, intellectual property strategies, and compliance requirements through a proven blended approach to custom analysis: review of technical knowledge, investigation of intellectual property, and appraisal of business impacts. Nerac deploys analysts in diverse disciplines to help clients discover new applications, serving as a catalyst for new thinking and creative approaches to business problems or identifying strategic growth opportunities.

SOURCE Nerac Inc.
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