Table 1.

Overview of medical device regulation in the European Union and United States

	EU	US
Market approval	Conformité Européenne (CE) marking must be obtained before marketing; once received, CE marking permits the device to be marketed throughout the EU	Food and Drug Administration premarket approval or clearance must be obtained before marketing; once received, FDA approval permits the device to be marketed in the US
Central regulatory agency	No	Yes (FDA)
Approval grantor	Notified bodies, which are private sector companies located across the EU. Companies may choose to use any notified body	FDA
Evidentiary standard for high risk devices	• Generally safety, performance, and reliability       • Clinical data are recommended for some high risk devices, but requirements can be variable across notified bodies	• High risk devices are approved through the premarket approval (PMA) pathway. PMA devices must provide valid scientific evidence from human clinical trials showing “reasonable assurance” of safety and effectiveness       • Subsequent changes to high risk devices are approved through PMA supplements, which may not include additional testing       • Certain high risk devices that are intended to treat rare diseases (<4000 patients in the US annually) may receive a humanitarian device exemption and be approved on the basis of “probable” benefits       • Moderate risk devices and some high risk devices can be marketed after gaining “clearance” through the 510(k) pathway, ordinarily without additional clinical data
Public access to approval decisions	• No	• Yes

In the EU and US, medical devices are regulated according to the level of risk accompanying their intended use. Moderate risk and high risk devices, which represent virtually all therapeutic and prescribed devices, are regulated differently in the EU and US.