In Vitro Diagnostic Medical Device Classification Program

Is this IVDMD intended to be used for blood grouping, or to determine foeto-maternal blood group incompatibility, or tissue typing to ensure the immunological compatibility of blood, blood components, cells, tissue or organs that are intended for transfusion or transplantation or cell administration?

Is this IVDMD intended for use in detecting the presence in cerebrospinal fluid or blood of an infectious agent with a risk of limited propagation?

Is this IVDMD intended for use in detecting the presence of an infectious agent if there is a significant risk that an erroneous result would cause death or severe disability to the individual, foetus or embryo being tested or to the individual’s offspring?

Is this IVDMD intended for use in pre-natal screening of women in order to determine their immune status towards transmissible agents?

Is this IVDMD intended for use in determining infective disease status or immune status, and where there is a risk that an erroneous result will lead to a patient management decision resulting in an imminent life-threatening situation or severe disability for the patient or for the patient’s offspring?

Is this IVDMD intended for use in screening for selection of patients for selective therapy and management as Companion Diagnostics (CDx)?

Is this IVDMD intended to be used for disease staging, where there is a risk that an erroneous result would lead to a patient management decision resulting in a life-threatening situation for the patient or for the patient's offspring?

Is this IVDMD intended for use in screening, diagnosis or staging of cancer?

Is this IVDMD intended for use in human genetic testing?

Is this IVDMD intended for use to monitor levels of medicines, substances or biological components, when there is a risk that an erroneous result will lead to a patient management decision resulting in an immediate life-threatening situation for the patient or for the patient’s offspring?

Is this IVDMD intended for use in the management of patients suffering from a life-threatening infectious disease?

Is this IVDMD intended for use in screening for congenital disorders in the foetus or embryo?

Is this IVDMD intended for use in screening for congenital disorders in new-born babies where failure to detect and treat such disorders could lead to life-threatening situations or severe disabilities?

Is the result of this IVDMD determining a critical situation?

Is this IVDMD an instrument intended by the manufacturer specifically to be used for in vitro diagnostic procedures?

Is this IVDMD a specimen receptacle?