Health Canada, the country’s regulating authority in the sphere of medical devices and other healthcare products, has published a guidance document dedicated to the current classification of in vitro diagnostic medical devices (IVDDs).
The document provides an overview of the IVDD classification basics and also describes in detail each of the classification rules and how they should be applied.
IVDD Classification Rules: Breakdown
As mentioned, the existing Canadian IVDD risk-based classification system is comprised of 9 classification rules divided into three groups.
The first group covers the rules to be applied in the case of in vitro diagnostic devices intended to obtain information about the disease status or immune status of individuals with respect to transmissible agents. This category covers medical devices intended for screening and diagnosis.
- Rule 1: IVDDs used for donor screening. According to the 1st rule, devices designed to detect the presence of a transmissible agent and intended for use in the course of transplantation are Class IV medical devices. The devices of this type are usually used to ensure the safety of components subject to transplantation (e.g., blood and its derivatives, human tissues, or organs). Should the result be positive, a component in question will be defined as the one that is not suitable for transplantation. These IVDDs could be based on the identification of the presence of infectious agents themselves or the antibodies thereto. This category covers any and all medical devices used for screening donated blood, as well as any other donated components. According to the document, it also applies to assays marketed for pyrogenicity testing of blood products, the detection of bacterial contamination of blood components, plasma pool testing in the manufacturing of blood derivatives or testing plasma prior to further manufacturing into blood products. The guidance also provides several examples of products covered by this category: they include the devices intended to detect Cytomegalovirus (CMV) or Human T-Lymphotropic Virus (HTLV). The authority also mentions that should the medical device intended to detect such components be labeled “Not for donor screening,” this rule should not be applied. In such a case, the device intended for general diagnosis and not donor screening will be covered by the scope of the 2nd rule and classified as Class III in vitro diagnostic medical device. At the same time, this rule has certain exclusions: IVDDs related to anti-HIV or HBsAg should still be classified as Class IV IVDDs.
- Rule 2: IVDDs used to determine disease status or immune status. According to the rule, an IVDD that is intended to be used to detect the presence of, or exposure to, a transmissible agent is classified as Class II. However, the rule also provides certain exclusions describing cases when such devices should be classified as Class III or Class IV IVDDs – mostly related to serious or life-threatening diseases. In general, in vitro diagnostic devices covered by the scope of the 2nd rule are intended to determine the disease or immune status. Health Canada also mentions that the concept of “detection” covers all types of assays, including first-line, confirmatory and supplemental ones. It is stated that these IVDDs are mostly marketed “as an aid to the diagnosis of …”. Under the general rule, the approach to classification of such devices should be based on the agents to be detected, the context in which they should be used (e.g. screening or diagnosing), and also on the characteristics of the agent (its pathogenicity and incidence), as well as the availability of treatment and the way the test results should be used in the decision-making process. For this purpose, additional attention should be paid to how inaccurate results could impact the patient or public health in general. At the same time, the scope of this rule does not cover in vitro diagnostic devices used for patient management. It is stated that the devices intended for patient management are usually assigned to the lower categories than the devices intended to diagnose the respective conditions. The particular classification to be applied will depend on the claims made by the medical device manufacturer and indicated in the labeling. The scope of this rule also does not cover the microbiological media, which is used to identify or infer the identity of a microorganism and cell culture media, or to serological or chemical reagents used for the confirmation of resulting cultures. According to the present guidance, such products should be classified as Class I devices. The in vitro diagnostic devices intended to be used in the context of infectious agents associated with low community risk should be classified as Class II IVDDs. This applies to those intended to identify infectious agents with limited spreading. Moreover, such devices are mostly used as one of multiple sources of information, so if the results obtained are not accurate enough, this could neither lead to severe consequences nor expose the patient to additional risks. This category covers in vitro diagnostic devices intended to detect such agents as Adenovirus, Bocavirus, Coronaviruses (except SARS), Helicobacter pylori, Rotavirus, Salmonella, and several others. At the same time, Health Canada emphasizes that should the infectious agent the device is intended to identify be related to a global outbreak, a higher classification rule could be applied. The Analyte Specific Reagents (ASRs) are the components used in laboratory-developed tests. Under the present classification rule, they are Class II medical devices. The 2nd classification rule also includes several subrules to be applied for certain specific in vitro diagnostic medical devices.
- Rule 3: IVDDs used for patient management. According to the 3rd classification rule, an in vitro diagnostic medical device that is intended to be used for patient management is classified as Class II, unless it falls into one of the [specific] categories, in which case it is classified as Class III. The rule also outlines the aforementioned categories, which cover medical devices intended to be used in the context of life-threatening diseases or situations. The 3rd rule should be applied in the case of in vitro medical devices intended for prognosis or monitoring of a disease or evaluating the effectiveness of treatment. The approach to classification of such devices is mostly based on the nature of the disease caused by the transmissible agent, the availability of treatment and the impact of an erroneous result to the individual being tested. It is also stated that results provided by medical devices falling within the scope of this rule are not critical, so such devices are classified as Class II IVDDs, except for certain exclusions provided in the subrules.
In summary, the first three classification rules describe how in vitro diagnostic medical devices should be classified depending on the transmissible agents they are intended to identify. The devices falling within the scope of these rules could be used for various medical purposes, including screening or diagnosis.
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