Medical devices designed, manufactured, sold or designed to be sold in the European economic area and outside of Europe are required to have the CE Marking. It is the manufacturer’s declaration that the product meets the appropriate regulatory requirements.
CE Marking is a certification mark that indicates conformity with health, safety, and environmental protection standards. It’s a recognizable standard worldwide. The mark consists of the CE logo and, if applicable, the four-digit identification number of the device in the conformity assessment procedure.
Medical Device CE Marking certificate is provided by a notification body after review of the technical file. US FDA reviews the files and gives approval.