Description: CE Marking, also referred as CE Mark is a legal requirement for medical devices (medical equipments) to market in the Europe. CE Marking (CE Mark) is recognized worldwide as a symbol of quality.
certification (1855) medical device (463) marking (165) ivd (126) ce marking (61) ce certification (13) ce certificate (5) class i (4) cemarking (1) ce logo (1)
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.
By affixing the CE marking, the manufacturer indicates that he / she takes responsibility for the conformity of the product. If importers or distributors market the products under their own name (OBL), the responsibility is transferred to the importer or distributor.
FDA Registration - FDA Certificate - FDA Agent
Best Affordable ISO 9001 Certification - Shortest Time - Free First Visit
Third Party Inspection
Liberty Management Group - Liberty Management Group
FDA Inspection – FDA 483 warning letter
FDA Registration - FDA Certificate - FDA Agent