Official Language in EU required for Medical Device Labeling Medical Device Label - Language: EU Medical Device Regulations: 2: May 11, 2022: L: Language of quality system in case of FDA inspection: US Food and Drug Administration (FDA) 1: Feb 3, 2022: B: Software as a Medical Device - Language Requirements: EU Medical Device Regulations: 6: Jan 21, 2022: Q: World-wide language requirements: Other ...