Self-control tests for the diagnosis of SARS-CoV-2 coronavirus infections

On 19 March 2021, the President of the Office for the Registration of Medicinal Products, Medical Devices and Biocidal Products announced that, in accordance with Article 11(2) of Regulation (EC) No 1254/1999, the commission had not 100 10 000 cases. Whereas Article 10 (1) of Regulation (EEC) No 2 2 of the Act of 20 May 2010 on Medical Devices (Journal of Laws of 20 May 2010). U. of 2020, item. 186 and 1493) it is permitted to provide and make available to persons who are not professional users tests intended for self-use ('devices for self-inspection') where:

  • in vitro diagnostic medical devices have been placed on the market as devices for self-inspection and are certified by a notified body (i.e. have been verified by an independent body), they may be placed in free circulation, i.e. they may be sold to any person.
  • such tests must include a clear wording on the packaging (marking) and instructions for use for self-testing and the number of the notified body which has certified the test at the CE mark.

At the same time, the authority indicates that serological tests cannot be used to detect SARS-CoV-2 infection, but can be used to detect antibodies in the body.