It is apparent that it is easier to have a medical device approved in the EU versus in the US, possibly due to the simplified yet still effective method of approval. Where the FDA takes into consideration devices being safe and effective, the EU focuses primarily on the risk factors. Whether it is effective is not a necessary criteria as it is with the FDA. In addition to the points that have been aforementioned, the separation of types of medical devices even before the more specific classifications creates a more manageable system in terms of approvals.