After 26 May 2022, medical equipment for in vitro diagnostics can only be put into use when these are CE marked. To obtain CE marking, the equipment must undergo a performance evaluation through clinical trials. These clinical trials are covered by the EU regulation on medical devices for in vitro diagnostics (2017/746/EU) and may not be initiated until a positive opinion is obtained from a scientific ethics medical committee.
The scientific ethics medical committee makes a scientific and ethical review of the case material. Emphasis is placed here on the fact that the clinical trials are designed and can be carried out in such a way that subjects are protected in terms of their rights, safety, dignity and welfare, which must come before all other interests, and that the data generated is scientifically substantiated , reliable and robust.
Clinical trials with medical devices for in vitro diagnostics that are not yet CE marked must meet the requirements described in Article 58 of the regulation, and clinical trials of already CE marked medical devices for in vitro diagnostics are regulated in Article 70 of the regulation.
It is thus the purpose of the test that defines what type of test it is and to which it must be reported.