Medical Device companies look to Europe for consistency in device review

This is the result of an interesting study conducted by Northwestern University. According to the study, two-thirds of US companies will seek regulatory clearance in Europe first, apparently as Europe's CE marking process is more predictable. As a consequence, 65 percent of devices were CE-marked before receiving FDA clearance. This difference is attributed to lack of clarity around the 510 (k) process, by which the vast majority of medical devices are cleared for the U.S. market. SMEs are particularly hard hit by this as approval time for their products is almost twice that as for large companies. This is a truly insightful report and well worth a read. It can be downloaded as a Powerpoint presentation here.