March 21, 2023

Can multiple different devices be on a single EU MDD/MDR DoC?

For a Declaration of Conformity (DoC) to a European Directive like 93/42/EEC on medical devices or to a European Regulation such as 2017/745 on medical devices, multiple different devices may indeed be encompassed by a single DOC. The Blue Guide reminds us that a single declaration of conformity can be made up of a dossier containing relevant individual declarations of conformity.  As long as all the required fundamental DOC contents/elements (e.g., per Annex IV of 2017/745, per Europe’s common framework for marketing of products, per EN ISO/IEC 17050-1 as amended, etc.) are clearly distinguished for each subject device, then a DoC including multiple devices should be good to go.