Paragraph 1 of MDR Art 19 / IVDR Art 17
The EU DoC shall state that the requirements specified in this Regulation have been fulfilled.
The EU DoC is a living document and the manufacturer shall continuously update it.
The EU DoC shall be translated into an official Union language or languages required by the Member State(s) in which the device is made available.
Paragraph 2 of MDR Art 19 / IVDR Art 17
If a manufacturer sells the devices in a Member State requiring also an EU DoC and if this EU DoC requires other aspects not covered by the MDR and the IVDR, then a single EU DoC shall be drawn up in respect of all Union acts applicable to the device.
The EU DoC shall contain all the information required for identification of the Union legislation to which the declaration relates.
Paragraph 3 of MDR Art 19 / IVDR Art 17
When signing the EU DoC, the manufacturer assumes the responsibility for compliance with the requirements of MDR/IVDR and requirements of other European legislation applicable to the device.