MEDDEV, NB-MED, EC Blue Guide & forms
MEDDEV and NB-MED documents were produced under the old MDD/AIMDD/IVDD framework (pre-2017). While some retain value as interpretive background, they must be read critically in the context of MDR/IVDR requirements. MDR/IVDR supersede these older documents where inconsistent. For current compliance questions, always refer to MDCG guidance first, then to MEDDEV only where MDCG provides no explicit guidance.