Clinical experimentation is a study on human beings aimed at discovering or verifying clinical, pharmacological and pharmacodynamic effects of one or more experimental medicinal products, medical devices or diagnostic/therapeutic techniques and procedures, in order to identify the benefits and the potential adverse reactions.

The manufacturer of medical devices not bearing the CE marking and used in clinical trials, or his authorized representative established within the European Community must send a communication to the Ministry of Health. The communication is necessary even if the clinical trials regarding the intended use of the device are other than those that were the subject of CE marking.

The support mechanisms in order to correctly project and execute a clinical investigation are the guidelines MEDDEV and the harmonised technical standards UNI-EN ISO 14155-1 & UNI-EN ISO 14155- 2 respectively, which define the conduct and execution of clinical investigations as well as the requirements for the preparation of a plan for clinical assessment (clinical protocol).

Di Renzo Regulatory Affairs has set up a specific unit for clinical experimentation of medicinal products and medical devices. This group consists of an employee with a degree in CTF (chemistry and pharmaceutical technology), a physician and an administrative member of staff, all with proven experience in the field