Declaration of Conformity Declaration of Conformity

The following BIOTRONIK products comply with the applicable provisions of the Medical Device Regulation (2017/745/EU) and the Radio Equipment Directive (2014/53/EU). This declaration is made under the sole responsibility of the manufacturer. 

Each document contains a signed English declaration of conformity and the following translations. As these are mere translations, they are not signed: Bulgarian, Czech, Danish, German, Greek, Spanish, Estonian, Finnish, French, Croatian, Hungarian, Italian, Lithuanian, Latvian, Dutch, Norwegian, Polish, Portuguese, Romanian, Slovak, Slovenian, Serbian, Swedish and Turkish.