In Vitro Diagnostics (IVD) help to detect diseases and other health conditions.
IVD products are devices and systems used to diagnose, treat, or prevent health conditions. They are meant to be used in the collection and examination of biological samples like blood, saliva, or tissue. Samples may be taken from inside the nose or the back of the throat, or from a vein or fingerstick.
It’s important to note that IVD products are noninvasive. However, they are still considered medical devices and are therefore subject to the same controls. Medical devices consist of any instrument, appliance, software, or related device intended to be used for human beings for the purpose of:
Manufacturers of In Vitro Diagnostics must meet the regulatory requirements of the European Union, the United Kingdom, and the U.S. depending on the market(s) they wish to penetrate.
These requirements include the In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746 in the EU and the UK Medical Devices Regulations (UK MDR) 2002 in the UK. In the United States, IVD products are defined in section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act); these devices may also be subject to section 351 of the Public Health Service Act, as well as categorization under the Clinical Laboratory Improvement Amendments (CLIA) of 1988.
According to the IVDR, an IVD product is defined as “any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body…”
Experts estimate that approximately 70% of all clinical decisions are made using IVD products.
Pregnancy tests, COVID-19 tests, and HIV tests are examples of IVD products. Other examples of IVD devices include:
Receptacles manufactured for medical specimens are IVD products as well. According to the World Health Organization, over 40,000 products are available for IVD testing today. These may range from traditional laboratory tests to point-of-care tests.
In the United States, the FDA classifies all medical devices—including IVD products—as Class I, Class II, or Class III. The device’s classification will vary based on the risk involved and the level of regulatory control needed to guarantee the product’s safety. Accordingly, the IVD classification will determine the premarket process the manufacturer needs to follow in order to bring their product to market.
It’s important to note that as the device class increases, the regulatory controls increase as well. Class I IVR devices are subject to the least regulatory control, while Class III IVR devices feature the most stringent requirements. Life Sciences companies looking to bring their In Vitro Diagnostic products to market in the United States can refer to the FDA’s “Classify Your Medical Device” resource.
Looking to ensure regulatory compliance in the European Union? The IVDR was upgraded in 2021 to include improvements such as:
Getting an IVD product to market safely and effectively is key—and understanding the regulations in place is an ideal first step.
IVD products are a critical line of defense against various health conditions. The safety and quality of In Vitro Diagnostics is essential, which is exactly why manufacturer regulatory compliance is so important.