It is easier to get device approval in EU than FDA.Regulatory process is less bureaucratic ,more efficient and more predictable than FDA.FDA requires both safety and efficacy of a device and it is becoming more difficult to conduct clinical trails in th U.S.due to FDA’s clinical data requirement .CE only require proof of safety and device performs in a manner consistent with manufacturer intended use..Timeline for obtaining CE mark is shorter than timeline for gaining FDA approval.FDA has the advantage of centralization and common rules,European union regulates medical drug and device approval through a network of centralized and decentralized agencies throughout its member state.