Rule 1: Devices intended to be used for the following purposes are classified as Class D: detection of the presence of, or exposure to, a transmissible agent in blood, blood components, cells, tissues, or organs, or in any of their derivatives, to assess their suitability for transfusion, transplantation or cell administration; detection of the presence of, or exposure to, a transmissible agent that causes a life-threatening disease with a high or suspected high risk of propagation; determining the infectious load of a life-threatening disease where monitoring is critical in the process of patient management.
Rule 2: Devices 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, or cell administration, are classified as Class C, except when intended to determine any of the following markers: ABO system [A (ABO1), B (ABO2), AB (ABO3)]; Rhesus system [RH1 (D), RHW1, RH2 (C), RH3 (E), RH4 (c), RH5 (e)]; Kell system [Kel1 (K)]; Kidd system [JK1 (Jka), JK2 (Jkb)]; Duffy system [FY1 (Fya), FY2 (Fyb)]; in which case they are classified as class D.
Rule 3: Covers a range of devices as reflected in its indents (a)-(m). Devices falling under Rule 3 (when not classified as Class D according to Rules 1 and 2) are to be classified in Class C, irrespective of the indent applied. It may be possible for a device to fall under more than one Rule 3 indent. Where this is the case, the most appropriate indent should always be applied based on the intended purpose of the device.
- a) Devices intended for detecting the presence of, or exposure to, a sexually transmitted agent.
- b) Devices intended for detecting the presence of an infectious agent in cerebrospinal fluid or blood without a high or
suspected high risk of propagation.
- c) Devices intended for 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, fetus, or embryo being tested or to the individual's offspring.
- d) Devices intended for pre-natal screening of women to determine their immune status toward transmissible
agents.
- e) Devices intended for determining infective disease status or immune status, 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 the
patient's offspring.
- f) Devices intended to be used as companion diagnostics.
- g) Devices intended for disease staging where there is a risk that an erroneous result would lead to a patient management decision that could result in a life-threatening situation for the patient or the patient's offspring.
- h) Devices intended to be used in screening, diagnosis, or staging of cancer.
- i) Devices intended for human genetic testing.
- j) Devices intended for monitoring levels of medicinal products, substances, or biological components when there is a
risk that an erroneous result will lead to a patient management decision, resulting in a life-threatening situation for the
patient or the patient's offspring.
- k) Devices intended for the management of patients suffering from a life-threatening disease or condition.
- l) Devices intended for screening for congenital disorders in the embryo or fetus.
- m) Devices intended for screening for congenital disorders in newborn babies where failure to detect and treat such
disorders could lead to life-threatening situations or severe disabilities.
Rule 4: Devices intended for self-testing are classified as Class C, except for devices for the detection of pregnancy, for fertility testing and for determining cholesterol levels, and devices for the detection of glucose, erythrocytes, leucocytes, and bacteria in urine, which are classified as Class B or Devices intended for near-patient testing are classified in their own right.
Rule 5: The following devices are classified as Class A: (a) Products for general laboratory use, accessories that possess no critical characteristics, buffer solutions, washing solutions, and general culture media and histological stains intended by the manufacturer to make them suitable for in vitro diagnostic procedures relating to a specific examination.
Rule 6: Devices not covered by the above-mentioned classification rules are classified as Class B.
Rule 7: Devices that are controlled without a quantitative or qualitative assigned value are classified as Class B.
Classification IVDR
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