5 key differences between IVD and medical devices
left: infusion pump (medical device); right: IVD
The International Electrotechnical Commission (IEC) provides standards for the safety and performance of medical devices, including in vitro diagnostic (IVD) devices. While both IVD devices and medical devices are subject to the same safety and performance standards, there are some differences between the two types of devices.
An IVD device is a medical device that is intended to be used for the examination of samples taken from the human body in order to provide information about a patient's health. IVD devices may be used for a wide range of purposes, such as diagnosing diseases, monitoring the effectiveness of treatments, or screening for health conditions. Examples of IVD devices include blood glucose meters, pregnancy tests, and laboratory analyzers.
Medical devices, on the other hand, are any instruments, apparatus, appliances, software, materials, or other articles that are intended to be used for a medical purpose, such as the diagnosis, treatment, or prevention of disease. Medical devices can be categorized into a number of different classes based on their risk level, with higher-risk devices requiring more rigorous safety and performance testing.
Here are five key differences between in vitro diagnostic (IVD) devices and other types of medical devices:
Purpose: IVD devices are specifically intended to be used for the examination of samples taken from the human body to provide information about a patient's health, while medical devices can be used for a wider range of purposes, such as diagnosis, treatment, and prevention of disease.
Sample Source: IVD devices use samples taken from the human body, such as blood, urine, or tissue, for their testing, while other medical devices may not require human samples at all.
Regulation: IVD devices are subject to specific regulatory requirements under the In Vitro Diagnostic Regulation (IVDR), while other types of medical devices are subject to different regulatory requirements under the Medical Devices Regulation (MDR).
Risk Classification: IVD devices are classified according to their level of risk, with higher-risk devices requiring more rigorous safety and performance testing, while other types of medical devices are also classified according to their risk level.
Standards: IVD devices are subject to specific safety and performance standards for in vitro diagnostic testing, while other types of medical devices are subject to more general safety and performance standards that may or may not be specific to their intended use.
Overall, while there are some similarities in the regulation and safety requirements for IVD and other medical devices, the specific purpose, sample source, and regulatory requirements for IVD devices set them apart from other types of medical devices.
