A systematic investigation involving one or more human subjects and conducted for the purpose of evaluating the safety or performance including clinical benefits of a medical device (as defined in the European Union’s Medical Device Regulation [EU MDR]). Clinical investigations may be conducted to demonstrate that a new medical device is safe and effective for its intended use, to gather clinical evidence required for regulatory approval or certification, to compare a medical device with existing treatments, or to evaluate long-term safety or performance after design changes or for new intended uses.
