Basics - IVDs in medical technology

Lukas Losigkeit

Lukas Losigkeit

CEO & Principal Consultant

What are IVDs?

In-vitro-diagnostic medical devices (IVDs) are a subgroup of medical devices.

In-vitro means that diagnostics is based on organic processes outside the living organism.

Vice versa, the term "in-vivo" means that something takes place inside the living organism.

IVDs are by definition intended for in vitro examination of samples taken from the human body. They provide information on the following points:

  • physiological or pathological processes or conditions,
  • congenital (congenital) physical or mental impairments,
  • the predisposition to a particular health condition or disease,
  • determination of the safety and tolerability of the potential recipients,
  • the probable effect of, or likely reactions to, treatment, or
  • definition or monitoring of therapeutic measures.

Sample containers are also considered to be in vitro diagnostic medical devices.

The best-known example of an IVD is probably a pregnancy test from the pharmacy. However, there are also a large number of other devices that are rather unknown but nevertheless important: Many IVDs consist of different reagents that are used in the laboratory, for example for the detection of a certain pathogen. These reagents are used to detect the DNA or RNA of the pathogen. Many tests on COVID-19 are based on this technology.

In-vitro-Diagnostics in medical technology

What role do IVDs play in medical technology?

The analysis of samples from the human body is very often used in diagnostics to detect various diseases. In this way, it is also possible to monitor drug treatment or to determine in advance whether it may be suitable.

In prenatal diagnostics, samples can be analyzed already from the embryo.

Example: Within the framework of in vitro fertilization, parts of an embryo can be removed in vitro using a weak laser (medical device, not an IVD) and analyzed using in vitro diagnostics. In this way various diseases or genetic defects can be detected. The separated cells do not damage the embryo. At this stage, the embryo is only a few days old and the separated cells are replaced as it grows.

In the context of the COVID-19 pandemic, the IVD industry has been in the focus of media and public attention. Suddenly it became clear to everyone what an important part IVDs play in medical technology and healthcare. What this period has also shown is the great adaptability and speed of this industry. The first COVID-19 tests were available in a very short time. This ability to adapt quickly is an important feature in this field. Because viruses and bacteria are constantly changing. An IVD manufacturer must be able to react quickly to this so that the mutated pathogens can also be reliably detected.

Why is this area so unknown?

As a patient, you usually have no contact with IVDs. You yourself, or a doctor takes a sample, which is then analyzed in the laboratory using an IVD. The patient then only receives the result - but how it came about in the laboratory is usually not known at all.

In addition, IVDs are often more abstract, more difficult to imagine. Most people know what an X-ray machine looks like. You can see at least parts of the device during use.

But any reagents that run various processes in conjunction with a blood sample to first isolate the DNA or RNA and then detect it - that is more difficult to imagine. And as I said, as a patient you don't notice anything about it. The doctor only tells you the result.

Another point for the relative unfamiliarity of IVDs is that there are few incidents or scandals with these products. IVDs usually do not have direct contact with patients and therefore have a much lower risk of harming them than is the case with standard medical devices.

How will the industry develop in the future?

The industry is growing very rapidly and is becoming increasingly important in diagnostics. New technologies in the field of genetic testing offer unprecedented opportunities. In particular, the transition from laboratory diagnostics to diagnostics at the patient's home will change our lives enormously. There are already more and more IVDs for home use. Most of them tend to measure different vitamin levels and hormones - this is not yet a revolution.

But imagine the following scenario:

Telemedicine is gradually establishing itself. So you don't have to go to the doctor personally for every little thing. One day you have a small device at home, into which you put a drop of blood and it is then analyzed. The result is available to the doctor and he will advise you by video call. That sounds like science fiction? But in vitro diagnostics in combination with telemedicine will offer such possibilities in the future. This will drastically improve our lives and the possibility for various preventive medical checkups.

Despite these possibilities, the industry is also facing problems. Surely you have already noticed that the new EU regulation MDR will bring great chaos to medical technology. The impact of IVDR is many times greater and the awareness of this impact is much lower compared to MDR. Why this is so and how it will continue, you will learn in our next article on in vitro diagnostics.