Spain

Medical Device Definition

Medical Device: means any instrument, apparatus, appliance, software, implant, reagent, material, or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:

• diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease,
• diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability,
• the investigation, replacement, or modification of the anatomy or a physiological or pathological process or state,
• providing information using in vitro examination of specimens derived from the human body, including organ, blood, and tissue donations,

and which does not achieve its principal intended action by pharmacological, immunological, or metabolic means, in or on the human body, which may be assisted in its function by such means.

Active Device: means any device whose operation depends on a source of energy other than that generated by the human body for that purpose or by gravity and which acts by changing the density of or converting that energy. Devices intended to transmit energy, substances, or other elements between an active device and the patient without significant change shall not be deemed active devices. Software shall also be considered to be an active device.

Invasive Device: means any device which, in whole or in part, penetrates inside the body, either through a body orifice or through the body’s surface.
Generic Device Group: means a set of devices having the same or similar intended purposes or commonality of technology, allowing them to be classified generically, not reflecting specific characteristics.

System: means a combination of products, either packaged together or not, which are intended to be interconnected or combined to achieve a specific medical purpose.

Medical Device Classification System

Regulatory Approval Process

Additional Information