"In the EU, every marketed medical device must carry a Conformité Européenne (CE) mark indicating that it conforms to relevant directives set forth in the EC Medical Device Directives of the EU. A device with a CE mark can be marketed in any EU member state. Medical devices that are non-implantable and considered low risk are “self-marked,” meaning that the manufacturer itself simply certifies compliance and applies a CE mark (30). High-risk devices must undergo a more extensive outside review."