Is the 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 or cell administration?

Is the device intended to be used 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 for the patient's offspring?

Is the device intended to be used for 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 device intended to be used for management of patients suffering from a life-threatening disease or condition?

Is it intended for the detection of pregnancy, for fertility testing and for determining cholesterol level, or for the detection of glucose, erythrocytes, leucocytes and bacteria in urine?

Is the device intended to be used in screening, diagnosis, or staging of cancer?

Is the device intended to be used 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, foetus or embryo being tested, or to the individual's offspring?

Is the device intended to be used for monitoring of 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 for the patient's offspring?

Is the device intended to be used for pre-natal screening of women in order to determine their immune status towards transmissible agents?

Is the device intended to be used for human genetic testing?

Is the device not covered by the above mentioned classification questions?

Is the device intended for detecting the presence of, or exposure to, a sexually transmitted agent?

Is the device intended to be used for 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, in order to assess their suitability for transfusion, transplantation or cell administration?

Is the device an instrument intended by the manufacturer specifically to be used for 

Is the device intended to be used for determining the infectious load of a life-threatening disease where monitoring is critical in the process of patient management?

Is the device a product for general laboratory use, accessories which possess no critical characteristics, buffer solutions, washing solutions, and general culture media and histological stains, intended by the manufacturer to make them suitable for 

diagnostic procedures relating to a specific examination?

Is the device a control without a quantitative or qualitative assigned value?

Is the device intended to be used for screening for congenital disorders in the embryo or foetus?

Is the device intended to be used for determining 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)];

Is the device intended to be used for detecting the presence of an infectious agent in cerebrospinal fluid or blood without a high or suspected high risk of propagation?

Is the device 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 the device intended to be used as companion diagnostics?

Is the device intendted to be used for 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?

Based on the previous answer(s), the following rules may apply to you.

Based on the rules of the IVDR, your product most likely falls under Class B.

clinical chemistry tests for hormones, vitamins, enzymes, metabolic markers, electrolytes and substrates

majority of anatomic pathology immunohistochemical assays

tests om infectieuze agentia op te sporen die een matig risico voor het individu vormen en niet gemakkelijk kunnen worden verspreid

control without a quantitative or qualitative assigned value (e.g. unassigned control sera, a DNA or RNA probe supplied for use as a non-assay specific normal control for in situ hybridisation (ISH))

If your device does not resemble the examples of a Class B device, please verify that your product is an in vitro diagnostic device.

The risk of your device is relatively high. A Notified Body must assess the device. Find out what must happen before this assessment can take place in the roadmap.

Class B

Based on the rules of the IVDR, your product most likely falls into Class C. The risk of your device is relatively high. A Notified Body must assess the device. Find out what must happen before this assessment can take place in the roadmap.

Class C

Based on the rules of the IVDR, your product most likely falls into Class A. The risk of your device is relatively low. The manufacturer self-assesses and self-certifies the device. Find out what needs to be done before this self-certification can take place in the roadmap.

Class A

class C - unless not D, by any other rule

Based on the rules of the IVDR, your product most likely falls into

 Class D. The risk of your device is very high. A Notified Body must assess the device. Find out what must happen before this assessment can take place in the roadmap.

Class D

Use the quickscan classification IVDR again to determine the class of the near patient testing device. 

Which class is your in-vitro diagnostic medical device?

Class:

Class
A

Class
B

Class
C

Class
D

Which class is your in-vitro diagnostic medical device?

Class:

ClassA

ClassB

ClassC

ClassD

Class
A

Class
B

Class
C

Class
D