what is ce with a medical device
CE Certification - Medical Device CE Marking. CE Marking (CE Mark) is a mandatory requirement for medical devices to market in the Europe. Medical Device category includes, medical equipments, medical softwares, medical & surgical disposables, etc... CE Marking (CE Mark) is recognized worldwide as a symbol of quality. It consists of CE logo and four digit identification number of the certifying notified body (if applicable). For a Medical Device manufacturer or Distributor, CE marking is the declaration that the product complies with all EU directives or EU regulations that apply to the medical device. CE marking does not implies that the product was made in the European Economic Area, but it states that the product is complying with the requirements of European Economic Area.