In vitro diagnostic (IvD) devices refer to medical devices that are used to examine biological samples from the body. In this process, the examination of the material takes place outside the organism. In vitro diagnostics require development and approval times of approximately four to six years.
What are in vitro diagnostics?
In vitro diagnostics (IvD) refer to medical devices used to test biological samples from the body. Thus, ivDs include specimen containers, rapid tests, test reagents such as urine test strips or hemoccult tests, swab materials, and analytical devices. According to the Medical Devices Act (MPG), in vitro diagnostic devices are medical devices for medical and self-testing use for the examination of biological samples such as blood, urine, stool, secretions or tissue samples outside the human body. Thus, IvD includes specimen containers, rapid tests, test reagents such as urine test strips or hemoccult test, swab materials and analyzers. Products for general laboratory use are generally not included in IvD except in cases where their characteristics, as defined by the manufacturer, require them to be used exclusively for in vitro examinations. In vitro examinations are intended to provide information about pathological or physiological conditions as well as congenital abnormalities. Furthermore, they serve to check for safety in potential recipients and monitor therapeutic measures. The manufacturer is responsible for determining their intended purpose. Thus, he also decides whether a product belongs to the in vitro diagnostic devices.
Function, effect, and objectives
Within the European Union, the marketing of in vitro diagnostic medical devices is regulated by the IVD Directive 98/79/EC. In Germany and Austria, this directive is implemented through the Medical Devices Act (MPG). According to this directive, in vitro diagnostic devices must bear a CE marking. Exceptions are custom-made devices, in vitro diagnostic devices manufactured in-house, devices for performance evaluation purposes and devices for clinical trials. The placing on the market or putting into service of custom-made devices and in-vitro diagnostic devices from in-house production is regulated under § 12 MPG. According to § 7 (5) MPV, for example, the conformity assessment procedure is mandatory for these products. According to this procedure, the manufacturer must issue a declaration for the identification of the product and assure that the product complies with the guidelines of the essential requirements. This declaration is made according to No. 2.1 of Annex VIII of Directive 93/42/EEC. Furthermore, according to No. 3.1 of Annex VIII of Directive 93/42/EEC, he must provide documentation on the description of the design, the manufacture and the actual performance data of the product. For in-vitro diagnostic devices from in-house production, the simplified regulations from § 5 Para. 6 MPV apply for corresponding application according to § 12 Para. 1 Sentence 3 MPG. According to this, the CE marking can be waived if a laboratory manufactures the in-vitro diagnostic devices only for its own use and no resale of the products produced takes place. However, the conformity assessment procedure and the technical documentation must be carried out. The CE marking of other in vitro diagnostic medical devices is a declaration by the manufacturer or distributor that the product complies with the harmonization legislation of the European Community concerning their affixing. The letters CE stand for “Comunidad Europea”, “Comunidade Europeia”, “Communauté Européenne”, “Comunidad Europea” and “Comunità Europea”, which means European Community (EC) in German. Because of this, CE was legally equated with EC in the 1980s, with the original CE mark being referred to as the EC mark in Germany under harmonization legislation. The CE mark is not a test seal, but an administrative mark. This administrative mark expresses the free marketability of the industrial products thus marked in the European Single Market. In contrast to other industrial products, medical devices are subject to special requirements for obtaining the CE marking. They must perform within the scope of the intended purpose specified by the manufacturer. The usefulness of the medical product to the patient must be demonstrated. The EC Declaration of Conformity and the CE marking of the product are required for the approval of in vitro diagnostic medical devices.
Risks, side effects and dangers
The approval process for in vitro diagnostics takes four to six years. For drugs, this period is almost twice as long. At the same time, testing is nowhere near as costly as for in vivo diagnostics because side effects and toxicity do not need to be studied in ivDs. The costs for this procedure amount to 5 to 15 million euros. The EC Directive 98/79/EC forms the basis of the approval procedure. According to this directive, IvDs are divided into four risk groups. These include general in vitro diagnostics, products for self-testing, and lists A and B. For the general IvD, the manufacturer can perform the conformity assessment on his own responsibility. For the devices for self-testing, the manufacturer has specified as intended purpose the use by lay persons in the home environment. These products include ovulation tests, pregnancy tests or menopause tests. IvDs in lists A and B are among the risk products that must be subjected to more detailed testing. List A includes products for blood grouping using the ABO system, the Rhesus system, and the Kell system, as well as rapid test detection for HIV, HTLV I, HTLV II, or hepatitis B, C, and D, respectively. List B includes products for blood grouping according to the Duffy system and the Kidd system. It also includes reagents for rapid test detection of rubella, chlamydia, toxoplasmosis and cytomegalovirus. Reagents for the detection of genetic disorders such as trisomy 21 (Down syndrome) or phenylketonuria are also in List B. The same is true for antigen detection of HLA isotypes A, B and DR as well as for the prostate specific antigen PSA. Last but not least, the reagents, devices and calibration materials for the blood glucose self-test are also listed there. According to §11 MPG, some in vitro diagnostic tests are only approved for sale to physicians and healthcare facilities. This applies to the rapid HIV test, among others.
