In Vitro Diagnostic Medical Device Classification Program

Is this IVD medical device intended to be used for blood grouping, or tissue typing to ensure the immunological compatibility of blood, blood components, cells, tissue or organs that are intended for transfusion or transplantation?

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

Is this IVD medical device intended for use in detecting the presence of an infectious agent where there is a significant risk that an erroneous result would cause death or severe disability to the individual or fetus being tested?

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

Is this IVD medical device 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 for the patient?

Is this IVD medical device intended for use in screening for selection of patients for selective therapy and management, or for disease staging, or in the diagnosis of cancer?

Is therapy decision when using this IVD medical device made only after further investigation or is this IVD medical device used for monitoring?

Is this IVD medical device intended for use in human genetic testing?

Is this IVD medical device 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?

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

Is this IVD medical device intended for use in screening for congenital disorders in the fetus?

Is the result of this IVD medical device determining a medically critical status?

Is the result of this IVD medical device preliminary and requires follow-up with the appropriate laboratory test?

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

Is this IVD a specimen receptacle?

Does this device require any procedure that is potentially hazardous, taking account of the nature of the substances involved, of the part of the body concerned and of the mode and route of administration?

Is this device intended to be used principally with wounds which have breached the dermis?

Is this device intended to be used principally with wounds which have breached the dermis and can only heal by secondary intent?

Is this a blood bag?

Can this device be connected to an active device in Class II or a higher class?

Is this device intended for channeling or storing body liquids or tissues, liquids, or gases for the purpose of eventual infusion, administration or introduction into the body?

Does the treatment of this device consist of filtration, centrifuging or exchanges of gas or of heat?

Is this device intended to be connected to an active medical device in Class II or a higher class?