It is easier to get devices approved in the EU than FDA:
1- FDA approval always requires a full clinical trial or trials, whereas the CE Mark in EU can be obtained through a clinical evaluation,a review of published data for existing equivalent devices.
2- The documentation required from investigators is much less efficient for FDA submissions than it is for the CE Mark.
3- The CE Mark is recognized almost globally, in addition to being valid in all countries of the European Union. By comparison, FDA approval is valid only in the United States. For this reason, it is more attractive to companies to apply for the CE Mark first.
4- Allows new technology to more quickly become available to patients compared with the FDA approval system (shorter time).
5- In EU For approval by a Notified Body (NB), devices are subject to performance and reliability testing linked to the risks of their intended use.
So, it is easier to approve a medical device in EU than FDA, however the good thing in FDA is that the FDA approves every step of the process that is required for a medication or surgical device to be used clinically, and it bases its approvals on the outcomes of large clinical trials and strict clinical evidence and outcomes. FDA approval indicates that strict criteria have been met, and that clinical application of a drug or device will be safe and effective. But in EU, CE mark leaves safety and efficacy of the surgical procedure that is performed by the device to the responsibility of the physicians and surgeons who use the device.