European Union

Austrian: BASG-ARS-CoV-2 rapid antigen test registry

Views : 4378
Author : Elisabeth
Update time : 2021-09-11 17:46:00

According to § 81 (4) Medical Devices Act 2021, SARS-CoV-2 rapid antigen tests can be placed on the Austrian market as self-tests even if the intended use of the rapid antigen test is for professional use. These tests are published online in the SARS-CoV-2 rapid antigen test registry (SARS-CoV-2-Antigenschnelltestregister) on the website of the Federal Office for Safety in Health Care (BASG). The search and filter function enables you to find specific products.

The registry lists all SARS-CoV-2 rapid antigen tests that have been registered with the BASG to date according to § 81 (4) of the Medical Devices Act 2021. No "approval"/validation/verification of these tests is carried out by the BASG as part of the registration. However, the manufacturer, his authorised representative or a distributor confirms via submission of a form to the BASG that during self-testing a safety and performance level is reached appropriate for the intended use. Furthermore, the SARS-CoV-2 rapid antigen tests must be CE-certified. National derogations do not fall under § 81(4) of the Medical Devices Act 2021 and must be reported to the BASG in the event of incorrect labelling.

The list in the registry does not claim to be complete. The information provided is accepted by the BASG without further verification. For questions regarding the function and safety of the tests, you are kindly requested to contact the manufacturers directly. In the event of a serious incident, please contact your physician first. He or she can discuss the further procedure with you. Health professionals are legally obliged to report serious incidents to the BASG.

Link:
https://www.basg.gv.at/en/market-surveillance/official-announcements/detail/sars-cov-2-antigenschnelltestregister?sword_list%5B0%5D=medical&sword_list%5B1%5D=devices&sword_list%5B2%5D=act&sword_list%5B3%5D=2021

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