| EU_CLASS_A | Klasse A In-vitro-Diagnostik - Niedriges Risiko | Class A Low-risk In-Vitro Diagnostics | Low-risk as specified in the final European In vitro Diagnostic Device Regulation (EU) 2017/746 | | x | x | x | |
| EU_CLASS_B | Klasse B In-vitro-Diagnostik - Niedriges bis mittleres Risiko | Class B Low-medium risk In-Vitro Diagnostics | Low-Medium risk as specified in the final European In vitro Diagnostic Device Regulation (EU) 2017/746 | | x | x | x | |
| EU_CLASS_C | Klasse C In-vitro-Diagnostik - Mittleres bis hohes Risiko | Class C Medium-high risk In-Vitro Diagnostics | Medium-high as specified in the final European In vitro Diagnostic Device Regulation (EU) 2017/746 | | x | x | x | |
| EU_CLASS_D | Klasse D In-vitro-Diagnostik - Hohes Risiko | Class D High-risk In-Vitro Diagnostics | High-risk as specified in the final European In vitro Diagnostic Device Regulation (EU) 2017/746 | | x | x | x | |
| EU_CLASS_I | Klasse I Medizinprodukt - Niedriges Risiko | Class I Low-risk Medical Device | Low-risk as specified in the final European Medical Device Regulation (EU) 2017/745 | | x | x | x | |
| EU_CLASS_IIA | Klasse IIa Medizinprodukt - Niedriges bis mittleres Risiko | Class IIa Low-medium risk Medical Device | Low-Medium risk as specified in the final European Medical Device Regulation (EU) 2017/745 | | x | x | x | |
| EU_CLASS_IIB | Klasse IIb Medizinprodukt - Mittleres bis hohes Risiko | Class IIb Medium-high risk Medical Device | Medium-high risk as specified in the final European Medical Device Regulation (EU) 2017/745 | | x | x | x | |
| EU_CLASS_III | Klasse III Medizinprodukt - Hohes Risiko | Class III High-risk Medical Device | High-risk as specified in the final European Medical Device Regulation (EU) 2017/745 | | x | x | x | |
