“In-vitro diagnostics is one of the most important fields in medicine today. It includes every type of laboratory testing of samples taken from the human body. Well-known examples include pregnancy and blood-sugar tests, but also tests for HIV. At TÜV SÜD, we certify these products. Firstly, we examine whether or not the tests perform as promised and secondly, whether they are safe and meet the legal requirements. Our clients include the most renowned and largest manufacturers in the industry.
Of course, we need highly qualified personnel for this task. A degree in the natural sciences is a prerequisite, and many of our colleagues have doctorates. Alongside this, relevant experience is another requirement—our employees should have been working in the field of in-vitro diagnostics for at least four years. At the moment, we have an unprecedented demand for new employees. Starting next year, the new EU regulation for in-vitro diagnostics will come into full force, according to which companies will only be allowed to self-certify their products in exceptional cases. This had previously been allowed if the company’s quality management system was audited by external providers.
The past two years have been very challenging for almost everyone working in the medical environment. At TÜV SÜD, for example, we coordinated with Germany’s Federal Institute for Drugs and Medical Devices regarding certification and approval of tests for the Covid virus. At times we were receiving up to ten inquires a day. We always view such tasks as an ethical obligation to patients, who must be able to rely on the safety of the products. The fact that we were able to ensure the safety of the corona tests with our screenings and thus contribute to containing the pandemic makes me proud.”
