DOC
Under the MDR (Article 19) and IVDR (Article 17), the manufacturer signs an EU declaration of conformity stating that the device meets the regulation. It is drawn up before the CE marking is affixed and kept up to date.
Under the MDR (Article 19) and IVDR (Article 17), the manufacturer signs an EU declaration of conformity stating that the device meets the regulation. It is drawn up before the CE marking is affixed and kept up to date.