CONSOLIDATE CE & FDA PROCESS
CE MARKING FOR HOSPITAL EQUIPMENT
CE Mark is affixed on products sold within the extended Single Market of the European Economic Area (EEA). This indicates that the products sold in the EEA have been assessed to meet certain standards. However, it does not imply that the EU authority or the FDA has approved a product.
CE Mark & FDA 510(k)
Medical Device and CE Marking
However, medical device manufacturers, importers, and distributors play a crucial role in ensuring the safety of products within the extended single market of the EEA. They are responsible for the conformity assessment, creating the technical file, issuing the EU declaration of conformity, and affixing the CE marking. In addition, importers and distributors must ensure that only medical devices complying with EU rules with CE Marking are distributed in the EEA market.