Medical technologies include drugs (medicinal products), medical equipment (incl. software), medical devices, IVD diagnostic devices, diagnostic and therapeutic procedures used in specific indications. Medical technology assessment – before introducing them to the market – provides, among others, answers to questions whether medical technology is effective? Is the safety guaranteed if the technology is used? Does the technology improve quality and efficiency compared to used alternatives?

One of the ways to verify the effectiveness and safety of medical technologies are medical experiments (EM) on participants. The EM participant is a person on whom the experiment is carried out directly. A medical experiment conducted with participants may be:

• a therapeutic (medical) experiment – introduction of new or only partially proven diagnostic, therapeutic or prophylactic methods for a direct benefit to the health of a patient person
• or a research (scientific) experiment – its purpose is primarily broadening the medical knowledge, therefore, it can be carried out both on a patient person as well as on a healthy one.

Clinical trials are part of medical experiments of a scientific nature, the results of which are the basis for introducing a given solution to the market. For a medical experiment, which is also a clinical trial within the meaning of Art. 2 sec. 2 point 2 of Regulation (EU) No 536/2014 of the European Parliament and of the Council of April 16, 2014 on clinical trials on medicinal products for human use and repealing Directive 2001/20/EC (OJ L 158 of 27/05/2014, p. 1, as amended 13), the provisions of the Act of March 9, 2023 on clinical trials of medicinal products for human use shall apply (Journal of Laws, item 605).

Clinical trials of medicinal products and medical devices may be, among others: of an observational or interventional nature. The purpose of observational trials is data collection and analysis. The purpose of interventional trials is to subject the participant to clinical trial interventions, which may include a medicinal product or a medical device.

It is worth noting that the study of biological material (including biological material collected from participants) is also a medical experiment.