What are In Vitro Diagnostic Devices (IVDDs)?

In vitro diagnostic devices incorporate all medical devices, including reagents, articles, instruments, apparatus, and equipment or systems to be used in vitro to examine specimens derived from the human body. In vitro diagnostic tests can be conducted on various samples, including blood, urine, and tissue specimens taken from the body, in an attempt to detect diseases or other conditions. They encompass a wide range of applications used to monitor a patient’s health status, such as screening, diagnosis (disease status), monitoring, prognosis, predisposition, and prediction.

Examples of in vitro diagnostic devices:

• Hepatitis or HIV tests
• Coagulation test systems
• Urine test strips
• Pregnancy tests
• Blood sugar monitoring systems for diabetics
• Receptacles manufactured explicitly for medical specimens

This definition can also include certain accessories, though they themselves are not in vitro diagnostic medical devices but are intended for use with those devices. They are, however, treated as separate from IVDDs regarding their regulation. Furthermore, products that are used only for veterinary medicine, as well as products for general laboratory use, are not subject to the same requirements as IVDDs. Conversely, devices used for self-testing, typically at home, are designated as IVDDs, though as a special group. Additionally, devices designed for performance evaluation studies outside the manufacturer’s facility must also conform to the relevant IVDD requirements.

IVDDs vs Medical Devices

In vitro diagnostic devices differ from other medical devices as they do not come in direct contact with the patient. IVDDs fulfill their role based on the knowledge and information they provide while offering no direct therapeutic value. As such, IVDDs have very different risk sets associated with them, derived from the accompanying risk to the patient (direct vs indirect risk). Risk assessment is generally tested and validated through experiments that evaluate how a medical device, or drug, performs on a patient; however, this approach is not possible for IVDDs.

Conversely, the quality of information delivered by the IVDD is evaluated according to the analytical precision of the test or assay and validated by the clinical evidence of the information provided. Precision is vital when performing various analyses, such as blood typing or screening for the presence of infections or diseases. Incorrect or inaccurate results can still have dire consequences for the patient, even if there is no direct contact. As such, IVDDs must have requirements to ensure the data they deliver meets exact performance criteria officially listed in the Common Technical Specifications, which are standards that control IVDDs. Thus, while a high level of safety and regulation is required for both medical devices and IVDDs, it is also essential to maintain the differences between these two categories of medical devices.

IVDD Labeling Requirements

Medical device labeling for IVDDs can include the labels for the inner and outer containers, the packaging, as well as any insert, brochures, leaflets, and user manuals included with the IVDD. The requirements for each differ slightly; however, the information provided should be expressed and presented with the intended user of the device in mind. It should contain clearly written step-by-step directions for use, with illustrations and drawings where appropriate, ensuring the user has a clear understanding of how to interpret certain results, including false positives or false negatives.

The immediate container is the packaging (vials, bottles, bags) designed to protect the contents (reagents, components) from contamination and the external environment. Any component that is used within a single kit must indicate the name of the component as well as the name of the IVDD. Simply using the component’s name should be sufficient for a multipurpose component that can be used with a number of kits. The container should also contain the name and address of the manufacturer, an identifier, such as a catalog number, as well as an expiration date and a lot number, in order to determine the complete manufacturing history of the product. Each reactive ingredient’s quantity, proportion, or concentration should also be listed, with the source and a measure of its activity provided for reagents derived from biological material. Finally, storage and handling instructions must be included, along with any warnings and precautions appropriate to the component.

The outer container must be labeled with much of the same information included on the immediate container. The primary differences include the expiration date that should be based on the component of the IVDD having the shortest projected useful life, an abbreviated intended use statement, and specific operating instructions. The outer container should also list the container’s contents, including quantities, volumes, and number of tests. This information will also allow the user to select a size suitable for their purposes.

Finally, package inserts have their own medical device labeling requirements, with the extent of the information required depending on the complexity and safety considerations of the test. Each device in the package must have a well-defined name that will enable the user to identify the device and distinguish it from other similar devices. The manufacturer should also assign a unique identifier along with the device’s name to permit any device to be easily distinguished. This may be a catalog number, model number, or barcode, which will provide an additional level of control and traceability in the marketplace. Furthermore, in addition to the name and address of the manufacturer, the insert can also contain the names and addresses of the importer or distributor.

Finally, the package insert must clearly indicate the intended use and indications of the IVDD, such as the nature of the intended use, the type of test (qualitative/quantitative), a description of the intended patient population, and a description of all parts or components supplied in the package. A brief summary and explanation of the test and how it works must also be present, including the clinical benefits and limitations of the test concerning the intended use. All this information should ideally be written at a level commensurate with the training of the expected user, enabling them to use the device without causing unnecessary harm to themselves or another person and to achieve the desired result.