T4485 Device risk class MDD/AIMDD/IVDD

Code value Name Description Used in Sweden
AIMDD Active Implantable Medical Devices (AIMDD) Class AIMDD for Medical Devices (according to EU Directive AIMDD 90/385/EEC) X
EU_CLASS_I Class I Medical Device - Low-risk Class EU_CLASS_I for Medical Devices (according to EU Directives MDD 93/42/EEC ) X
EU_CLASS_IIA Class IIA Medical Device - Low-medium risk Class EU_CLASS_IIA for Medical Devices (according to EU Directives MDD 93/42/EEC ) X
EU_CLASS_IIB Class IIB Medical Device - Medium-high risk Class EU_CLASS_IIB for Medical Devices (according to EU Directives MDD 93/42/EEC ) X
EU_CLASS_III Class III Medical Device - High-risk Class EU_CLASS_III for Medical Devices (according to EU Directives MDD 93/42/EEC ) X
IVDD_ANNEX_II_LIST_A IVDD Annex II List A IVDD Annex II List A as specified in European In Vitro Diagnostic Devices Directive (IVDD 98/79/EC) X
IVDD_ANNEX_II_LIST_B IVDD Annex II List B IVDD Annex II List B as specified in European In Vitro Diagnostic Devices Directive (IVDD 98/79/EC) X
IVDD_DEVICES_SELF_TESTING IVDD devices for self-testing Class EU_CLASS_SelfTest for In-Vitro Diagnostic Devices (according to EU Directive IVDD 98/79/EEC) X
IVDD_GENERAL IVDD General Class EU_CLASS_General for In-Vitro Diagnostic Devices (according to EU Directive IVDD 98/79/EEC) X
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