A clinical study with a medical device is an investigation that aims to evaluate the safety, functioning and performance of a medical device during its use.

A medical device is defined as any instrument, device, equipment, computer program (with or without artificial intelligence), implant, reagent, material or other article intended by the manufacturer to be used in humans, separately or in combination, for any of the following specific medical purposes:

• Diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of a disease.
• Investigation, replacement or modification of the anatomy or of a physiological or pathological process or state.
• Obtaining information through the in vitro examination of samples from the human body, including donations of organs, blood and tissues, and which do not exert their main intended action inside or on the surface of the human body by pharmacological, immunological or metabolic mechanisms, but to whose function these mechanisms may contribute.
• Products for controlling or supporting conception.
• Products specifically intended for the cleaning, disinfection or sterilization of products.

Documents to be provided as part of the protocol

• IDIAPJGol application form.
• Investigator’s manual or technical sheet of the medical device.
• Commitment to request AEMPS authorization in case of not having a CE certificate and/or not using it for the intended purpose.
• Patient information sheet and Informed Consent.
• AIPD (if applicable).
• List of centers and researchers.
• CVs of the IPs of each center (if applicable).
• Suitability of the facilities*.
• Conformity of the management of the participating centers*.
• Insurance policy*.
• Economic report.
• Payment of fees or exemption from payment.

* It is not necessary in clinical research with CE marked medical devices in which it is used within the intended purpose (does not require notification to the AEMPS)..

Mandatory sections within the protocol

• Registration in REec or Clinical Trials (recommended).
• Health product safety management.
• Procedures and materials used for subject recruitment (if applicable).

Data Protection Impact Assessment (DPIA)