Notified Body Preparations For New Regulations Reveal Some Horror Stories
Executive Summary
Despite a sense of urgency to have notified bodies redesignated under the EU’s new medical device regulations, it seems that some are happy to wait. Bassil Akra of TÜV-SÜD, a Germ-based notified body, warns manufacturers of the pitfalls ahead and what to watch out for in notified bodies they work with.