Medical device regulations Easier access to self-tests

The amendment to the Medical Devices Ordinance (MPAV) came into force today. On this occasion, the Association of the Diagnostics Industry (VDGH) points out an important simplification for consumers: The legal framework for the dispensing of diagnostic tests for self-use by laypersons ("self-tests") has been extended.

Previously, the distribution of self-tests to detect a pathogen or infection was severely restricted under the Infection Protection Act or only permitted in exceptional cases. During the coronavirus pandemic, the rules for self-tests were relaxed, which proved helpful. Now the ban on laypeople giving tests has been lifted in principle.

"This makes access to self-tests much easier," says Dr. Martin Walger, Managing Director of the VDGH. "In future, people will be able to use a variety of diagnostic tests on their own responsibility to obtain early indications of health problems. This strengthens the population's health literacy and can guide the use of the healthcare system in a targeted manner."

The coronavirus pandemic has shown that self-administration of diagnostic tests by laypeople works well. Modern self-tests are safe and reliable. They undergo strict approval procedures and must prove their user-friendliness.

The VDGH emphasizes: self-tests do not replace medical diagnostics, they complement them in a meaningful way. Self-testing can contribute to the early detection of pathogens, break chains of infection and pave the way for further medical clarification.

In a nutshell: The Association of the Diagnostics Industry (VDGH)

As a trade association, the German Diagnostics Industry Association (VDGH) represents the interests of more than 100 companies operating in Germany with a total turnover of 5.4 billion euros in 2023. They manufacture examination systems and reagents for the diagnosis of human diseases, which generate a turnover of more than 2.3 billion euros, as well as instruments, reagents, test systems and consumables for research in the life sciences, which generate a turnover of 3.1 billion euros.

www.vdgh.de

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