Grouping in-vitro diagnostic medical devices (IVD) is similar to general medical devices. The groups especially for IVD medical devices are as following, whereby there is no SET grouping for IVDs:

  1. 1. Single,
  2. 2. System,
  3. 3. Family,
  4. 4. IVD Test kit,
  5. 5. IVD Cluster.

Three basic rules must be fulfilled by IVD devices to be grouped together, i.e.:

a. One proprietary name;

  1. b. One manufacturer name and;
  2. c. One common intended purpose.

In the newly issued guidance document by MDA, there are additional explanations and examples provided on the groupings. MDA has included specific groups of IVD devices in Section 6 IVD Devices Specific Grouping, which are:

  1. 1. Immunohistochemistry (IHC) IVD Reagents.
  • - Intended use to identify, by immunological techniques, antigens in tissues or cytologic specimens, and excludes reagents specifically intended to be used with flow cytometry.
  1. 2. Fluorescence in Situ Hybridization (FISH) Probes In-vitro Diagnostic Reagents
  • - That allows for the detection and localization of the presence or absence of specific DNA sequences on chromosomes, whereby the hybridization of the probes with the DNA site will be visible using fluorescence microscopy.

There are lists of examples, permissible variants for family grouping, and a flowchart introduced in this guidance document, serving as an extension of the MDA/GD/0005 Guidance Document of Product Grouping focused on IVD devices.




MDA/GD/0054 Guidance on the Product Grouping for In-Vitro Diagnostic (IVD) Medical