FOCUS ZONE REPORT – BSI is launching a new speed-to-market programme, CE-Onsite FastTrack Review, for Class III medical devices needing European CE Marking Design Dossier Reviews.
The new programme, which is designed to speed up the review process through live, onsite interaction, enabling more efficient communication, aims to complete the review process in 45 working days.The CE-Onsite has the same features of the CE-45 FastTrack Programme, with one main difference: BSI Product Experts visit the manufacturer's premises to perform the review. As an industry norm, reviews are conducted via mail, email, fax and telephone and the process can take months. However, performing reviews onsite allows for a much faster timeline while still maintaining the same high quality. This face-to-face opportunity provides Product Experts accessibility to all relevant parties, from engineers to regulators, and supports dynamic communication, immediate access to documentation and in-person viewing of the new product. The new premium programme is not for everyone or every product. As with the CE-90 and CE-45 programmes, some products such as medicinal, blood and animal tissue products, require the use of outside agencies and may not be eligible for CE-Onsite Review. In addition, while BSI's goal is to complete the review with either a positive or negative recommendation within 45 working days, the length of the review greatly depends on the degree to which the manufacturer is prepared. In order to make the review as effective as possible, clients should have a strong motivation to get their product to market and excellent documentation, and be well-organized and responsive to questions. Manufacturers utilising the CE-Onsite have experienced numerous advantages including shorter launch times, patients gaining access to new technology sooner and quicker return on investment. 'The interactive aspect of the CE-Onsite FastTrack Review compresses the review time, improves the predictability of the review's outcome, and promotes a faster time-to-market,' explained Ibim Tariah, technical director of BSI, Healthcare. 'BSI provides thorough and fair reviews that focus on what really matters, but we never guarantee a CE Marking. The integrity of each review is critical to ensuring a medical device is deemed safe for its intended use.' BSI Product Services, Healthcare is a world-class Notified Body, dedicated to providing rigorous regulatory and quality management reviews and product certifications for medical device manufacturers. BSI has been conducting business in more than 100 countries for over 100 years. The organisation’s experienced healthcare team specializes in high-risk, invasive, combination and implantable products. BSI services include CE Marking, ISO 13485, CMDCAS, Japan PAL, FDA Accredited Persons Inspections, Standards and Training. |
