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Clinical Literature Reviews: Changes in the European Union's Medical Device Directive Require Manufacturers to Take Immediate Steps to Comply

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Executive Summary

With a rapidly approaching March 2010 deadline to comply with the European Union's revised Medical Device Directive, Nerac advises that manufacturers, now faced with an enormous amount of work to complete in a short period of time, take immediate steps to deal with the coming changes. 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. 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. Applying Nerac's expertise in clinical research, companies can begin analyzing their product data now to make certain that they have initiated the required procedures to prevent disruptions to their sales pipelines.

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