Our lawyers have extensive experience in legal assessment of all types of clinical and non-clinical projects. We also assess whether a given medical procedure, including a medical device, can constitute a therapeutic experiment within the meaning of the Polish law.
Contrary to common understanding, a medical company may encounter clinical tests not only at the stage before marketing the device. The medical company can independently conduct safety or efficiency tests after marketing the drug. Where such test meets certain legal requirements (e.g. the use of the device complies with the manual), such a test shall not be subject to the legal requirements related to the full clinical test (registration, insurance, documentation, etc.).
The medical company also has the full right to conduct non-clinical tests (e.g. research on procedure habits, marketing research, sales research, etc.). The help of a lawyer is useful at the stage of designing research and building advertising claims based on such research.