The CE mark that appears on a product (such as a medical device) or on its packaging means that the product satisfies the relevant essential requirements of the EU regulations and is fit for its intended purpose as specified by the manufacturer. The letters “CE” are the abbreviation of French phrase “Conformité Européene” which literately means “European Conformity”.
All medical devices and IVDs, (except custom-made devices and those intended for clinical investigations) must bear a CE mark.
The CE Marking on a product is a manufacturer’s declaration that the product complies with the essential requirements of the relevant European health, safety and environmental protection legislations in practice by many of the so-called Product Directives (i.e. MDD, IVDD). Product Directives contains the “essential requirements” and/or “performance levels” and “Harmonized Standards” to which the products must conform. Harmonized Standards are the technical specifications (European Standards or Harmonization Documents) which are established by several European standards agencies (CEN, CENELEC, etc).
Please take note that the CE-marking process will change under the MDR and IVDR. The notion of Product Directives will be obsolete.
When an IVD product has been approved by European Authorities, it must bear the CE logo and the IVD logo. The term “CE-IVD” is then used.