Application of the Rules - Flow Diagram Part 4

"Other Uses" not for transmissible diseases

Rule 4 continued

An IVDD used for diagnosis or patient management is classified as Class II unless they are used for the following, then they are Class III:

• It is used for disease staging;
• It is used to monitor levels of drugs, substances, biological components where an erroneous result would lead to a patient management decision resulting in imminent life threatening situation for the patient.

Rule 5

An IVDD intended to be used for blood grouping or tissue typing is Class III.

Rule 8

An IVDD is a Class I if:

• It is not used for diagnosis or patient management for diseases not caused by transmissible agent;
• It is not intended to be used for blood grouping or tissue typing;
• It is not used with regard to transmissible agents;
• If it is listed in the table of Rule 9.