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Bonn (dpa) - The Federal Institute for Drugs and Medical Devices has issued the first three special approvals for corona tests for self-use by laypeople.
A spokesman announced on Wednesday.
In all three tests, the samples would be obtained by swabbing the front of the nose.
According to the studies submitted by the manufacturers, this can be safely carried out by laypeople, the Federal Institute explained.
Before issuing a special approval, the Federal Institute not only checks the technical functioning of the test.
There is also the question of whether the test can be safely used by laypeople.
This includes, among other things, understandable operating instructions, it was said in advance.
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As of February 12, almost 30 applications for special approval of the corresponding tests had been submitted to the Federal Institute.
According to the information at the time, the applications are checked with the highest priority in order to make such rapid tests available as quickly as possible.
So that the tests can be safely used by laypeople and make an effective contribution to fighting pandemics, diligence is the top priority in the test procedures, explained the Federal Institute.
Federal Minister of Health Jens Spahn (CDU) said on Wednesday morning on ZDF: "I assume that we will be able to approve more, special approvals, as early as next week."
The regular way of bringing medical products onto the market, on the other hand, is the CE marking by certification bodies. Regardless of the special approvals, the Federal Institute also expected further antigen tests for lay use on the regular route.
In addition to vaccinations, rapid tests are an important component in containing the pandemic.
The topic has gained further importance due to the rapid spread of the still more contagious Corona variant, which was first discovered in Great Britain, as well as the opening steps that have taken place in daycare centers and schools.
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The previously available corona rapid tests have also been approved for use by non-medical personnel after training since February 2.
Health Minister Spahn had initially announced that from March 1st, all citizens would be offered to be tested free of charge by trained staff with rapid antigen tests - for example in test centers, medical practices or pharmacies.
However, this should only be discussed at the next federal-state consultations on the pandemic on March 3.
© dpa-infocom, dpa: 210224-99-569342 / 2
Communication from the Federal Institute