Declaration of Conformity

  • Name, registered trade name or registered trade mark and, if already issued, Single Registration Number (SRN), and, if applicable, its authorized representative, and the address of their registered place of business where they can be contacted and their location be established;
  • A statement that the EU declaration of conformity is issued under the sole responsibility of the manufacturer;
  • The Basic Unique Device Identification Device Identifier (UDI-DI);
  • Product and trade name, product code, catalogue number or other unambiguous reference allowing identification and traceability of the device covered by the EU declaration of conformity.
  • Risk class of the device;
  • A statement that the device that is covered by the present declaration is in conformity with the MDR/IVR and, if applicable, with any other relevant European legislation that provides for the issuing of an EU declaration of conformity;
  • References to any Common Specification (CS) used and in relation to which conformity is declared;
  • Where applicable, the name and identification number of the notified body, a description of the conformity assessment procedure performed and identification of the certificate or certificates issued;
  • Where applicable, additional information;
  • Place and date of issue of the declaration, name and function of the person who signed it as well as an indication for, and on behalf of whom, that person signed, signature.