Boston Biomedica Inc announced that seven of its Accurun 1 Positive Control products designed for the European market have been 'approved to CE Mark' by G-Med, a designated Notified Body under the European Union's In Vitro Diagnostics Directive. The IVD Directive describes criteria that must be met and steps that must be taken for IVD products to be qualified for sale in European Union countries beginning at the end of 2003.
In the IVD Directive, the European Union classifies products according to the risks associated with their failure or misuse, and establishes a process leading to a CE Mark (approval to sell a product in EU countries) for each category. BBI's Accurun 1 product line is in the highest risk category because these products are intended for use with tests for HIV and Hepatitis B and C; thus the criteria for approval to CE Mark are the most stringent, and require Notified Body review.
"Our staff, under the direction of Debbie Petit, Senior Manager of Regulatory Affairs for BBI Diagnostics and Project Leader for the CE Marking Team, has gained valuable experience in reaching this goal of approval to CE Mark for the Accurun 1 product line," said John Swatosh, Director, Sales and Marketing for BBI Diagnostics. "We chose to clear the highest hurdle first, because Accurun 1 is our biggest-selling quality control product.
"Approval to CE Mark for Accurun 1 products is another important step in support of our TQS sales in European Union countries," said Kevin Quinlan, President & Chief Operating Officer of Boston Biomedica Inc. "Together with the ISO13485 Certification, this approval sends a clear message to our international distribution network that they can count on BBI to work with them for approval of our products within their regulatory systems, and demonstrates our commitment to attain the highest quality standards in existence throughout the world."