As mentioned in our Classification and Grouping Ultimate Guide, there are a series of rules to consider when classifying and grouping In Vitro Diagnostic devices in Costa Rica. Such rules are fully explained in Annex A.2. – Decree No. 43902-S by the Ministry of Health.
In this article, we will focus on explaining strategies to classify and group In-Vitro Diagnostic products (IVDs) following simple general rules and explaining some particularities that can be found in these types of devices according to our everyday experience.
General characteristics of an In-Vitro Diagnostic device
In Costa Rica, In-Vitro Diagnostic (IVD) products are classified as Medical Devices. The Ministry of Health outlines their classification in Decree No. 43902-S, which also classifies other Medical Devices. However, there are nine specific rules that apply solely to IVDs, detailed in a distinct section of Appendix A.
IVDs are generally comprised of reactants, controls, calibrators and equipment or devices on which the diagnosis is performed. The evaluated parameters or analytes through these IVDs are many and each diagnosis process varies depending on different factors, such as: the technology, the analytical measurement technique, the type and size of the sample and the expected accuracy/precision. All these variables must be considered during the classification and grouping evaluation.
It is worth mentioning that IVDs can be part of a medical diagnosis equipment and sold together with it, but in terms of their regulatory treatment they are considered as independent medical devices. A glucometer is a good example, since the device itself is considered as medical equipment and the test strips as IVDs.
Every point described so far has regulatory implications that we will explain in the following sections.
Classification according to the level of risk
In-Vitro Diagnosis products are classified as follows, in general terms, according to their level of risk:
Class 1 IVDs (lowest risk):
- Microbiological media used to identify or infer the identity of a microorganism (except for media class 2 or class 3 specified in Rule 8.)
- EMB-DIV to which rules 1 to 8 do not apply.
Class 2 IVDs (moderate risk):
- Personal use IVD tests for pregnancy detection or fertility and those to determine cholesterol levels (Rule 6).
- Media for antimicrobial sensitivity tests (Rule 8).
- Chromogenic media (Rule 8).
- EMB intended to detect the presence or exposure to a transmissible agent (Rule 2), unless classified under any exception.
- EMB intended for patient management (Rule 3), unless classified under any exception.
Class 3 IVDs (higher risk):
- EMB for detecting severe transmissible agents, sexually transmitted agents, infectious agents in cerebrospinal fluid or blood, and situations where incorrect results could cause death or severe disability (Rule 2).
- EMB for managing potentially fatal diseases, cancer detection, genetic testing, congenital disorder detection in fetuses, disease staging, and monitoring critical medications, substances or biological components (Rules 3 and 4).
- EMB for blood or tissue typing for transfusions or transplants, in vitro diagnostic devices for personal or professional use outside clinical labs (except for the exceptions specified in Rule 6) and chromogenic media for identifying sexually transmitted agents. (Rules 5, 6, and 8).
Class 4 IVDs (highest risk):
- EMB intended to detect the presence or exposure to a transmissible agent in blood, blood components, blood derivatives, tissues, or organs to evaluate their suitability for transfusions or transplants (Rule 1).
- EMB intended to detect the presence or exposure to a transmissible agent that causes a potentially fatal disease with a risk of spreading in the population (Rule 2).
Considering this classification, in article 8 of Decree 43902-S, it is ruled that in the case of an in vitro diagnostic EMB including analyzers, reagents and software, which are used with another in vitro diagnostic EMB, both will be classified in the category that represents the highest risk.
Thanks for reading this article, if you have any questions about this topic, feel free to contact us at [email protected] or check our guidelines.
