Obtaining CE Mark Certification using Clinical Literature Reviews
Maintaining Compliance with the EU Medical Device Directive by utilizing Clinical Literature Reviews by an Objective Third Party Reviewer
The European Market for Medical Devices is estimated at over $86 billion, with expected annual growth of at least 5% over the next several years. In order for medical devices to be approved for sale in the European Union member countries they must be certified with a CE mark, which indicates conformity to the Medical Device Directive 93/42/EEC and other applicable industry standards.
A new revision of the directive, MedDev 2.7.1 Rev 3, “Clinical Evaluation: A Guide for Manufacturers and Notified Bodies” was released in December 2009, and supplements the original requirements by offering specific requirements and guidelines for medical device manufacturers to demonstrate the safety and efficacy of devices through a review and analysis of clinical performance data.
It is imperative for medical device manufacturers to achieve and maintain compliance with this guideline as part of the CE Mark certification process. At stake is maintaining or increasing share in the growing $86 billion European market that accounts for a significant percentage of most U.S. medical device manufacturers profits.
This white paper examines the use of clinical literature data as an acceptable and practical alternative to clinical trials, not only for new product introductions, but also for previously CE-marked devices which have been on the market for several years.
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