EU declaration of conformity
Short definition
The EU declaration of conformity is the document in which the manufacturer states, under its own responsibility, that the device meets the requirements of Regulation (EU) 2017/745.
In plain language
It is laid down in Article 19 of the MDR and its minimum content is set out in Annex IV. It is issued before the CE marking is affixed and must be kept up to date. For ordinary Class I devices, it is the centrepiece of the self-declaration of conformity.