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BSI announced the launch of CE-Dedicated FastTrack. This new CE marking program is designed to help medical device manufacturers get their products quickly and safely to European markets. CE-Dedicated FastTrack offers reviews at an accelerated pace, within 45 working days or less. A key feature of the program is that BSI Product Experts dedicate a period of time to work exclusively with a particular client to complete the review, therefore travelling to the customer site is not required. CE-Dedicated leverages a range of communication technologies, paperless submissions and expertise that can quicken the review process to get new medical devices into the European market providing patients access to new technology.
CE-Dedicated is the fourth in a series of BSI Speed-to-Market Programs designed for Class III medical devices requiring CE marking design dossier reviews. Programs include: CE-90 standard, which completes most reviews within 90 working days from submission; CE-45 FastTrack, expedited reviews within 45 working days; and CE-Onsite FastTrack in which BSI Product Experts conduct reviews at the customer’s premises targeted at 45 working days.
“By utilizing high-tech capabilities, we provide a dynamic and personalized information interchange over geographic distances that streamline the entire review process,” states Ron Rakos, Vascular Team Leader, BSI Healthcare.
CE-Dedicated is not designed for all products, such as ones containing medicines, animal or blood derivatives that require the use of outside agencies and may not be eligible. Although BSI cannot guarantee a positive recommendation, the CE-Dedicated review provides manufacturers the benefit of knowing where they stand sooner in the process and a progress report for briefing upper management. The complexity of the product, timelines and regulatory requirements impact which program is best suited to the client’s needs. BSI works with clients to determine the right fit for each product.