Archive for the ‘EU Directive’ Category
Review a clinical literature review written by Nerac analysts, Marco Bafan and Deb Schenberger, Ph.D. discussing the upcoming changes and new requirements of the amended European Union Medical Device Directive that take effect in March 2010. Go to http://www.nerac.com/nerac_insights.php?category=reports&id=143.
Medical device manufacturers are scrambling to update their technical files for CE Mark certification, based on the changing requirements of the EU Medical Device Directive. EU MEDDEV 2.7.1 outlines the pathway for clinical literature reviews to be conducted to demonstrate safety and efficacy without the need for clinical trials. This has proven to be a valid methodology, reviewed favorably by notified bodies for CE Mark certification. The FDA will also consider clinical literature reviews as part of a pre-market approval submission. Most activity has been seen with Class II devices; Class I devices are generally not subject to the same requirements. Class III devices are reviewed most stringently for market approval and/or CE Mark certification, hence clinical trials are likely the preferred route to demonstrate safety and efficacy.
How can device manufacturers mantain compliance for their already marketed products, while also trying to market new products? How costly is this process? What happens if manufacturers cannot meet the March, 2010 deadline for compliance with the Directive? What constitutes a valid literature review?
Shared experiences, questions and comments are welcome.