The new IDV classification rules are as follows:

1. Devices are classified as class D if they are used for:

 Blood screening of blood components, cells, tissues or organs for transfusion,

transplantation or cell administration
 Detection or exposure to high-risk disease
 Determining infectious load of a life-threatening disease for which monitoring is crucial
to patient management

2. Devices are classified as class C for blood grouping or tissue typing to ensure
immunological compatibility of blood, blood components, cells, tissues or organs
intended for transfusion, transplantation or cell administration. Exceptions to the rule are
ABO, Rhesus, Kell, Kidd and Duffy systems, which must be classified as class D.
3. Devices must be classified as class C if they are used for:

 Infectious disease
 Cancer testing/ disease staging
 Companion diagnostics
 Genetic testing
 Congenital screening of embryos, fetuses or new-born babies

4. Devices must be classified as class C if they are intended for self-testing. Exceptions to
this rule include self-tests for non-critical conditions such as pregnancy, fertility,
cholesterol and devices that detect glucose, erythrocyte, leucocytes and bacteria in urine
(class B)
5. Devices that are classified as class A:

 Products for general laboratory use, accessories with no critical characteristics, specimen
receptacles and specific IVD reagents

6. This rule is for devices not covered in any other classification rule
7. This rule applies to devices which are controls and have no quantitative or qualitative
assigned value

Summary of the new IVD classification system with examples:

Most importantly for medical device and IVD manufacturers is that these changes will greatly affect
the way current and future devices and diagnostics are classified, which will in turn impact
manufacturing, clinical evidence and conformity requirements. Missing the mark with classification
can mean that the product falls short in other key areas and cannot be approved for use by patients.

It is advisable to contact a management consultancy that specialises in the medical devices industry
to assist with the intricacies of the new classification system. This could help companies to
understand the complex terminology, ensure that they interpret the rules correctly and assist with
formulating a plan of action.

ProClinical, a recruitment agency that has many years’ experience in the medical device industry,
has partnered with management consultancy Trinzo to guide medical device companies through
the new classification system, as well as helping with the many other challenges that companies
following the MDR and IVDR. Download our MDR and IVDR whitepaper for more information on
how to prepare. Alternatively, you can set up a consultation to discuss your needs with an expert