A medical device, as defined by the Decree n° 46 of 1997, is "any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the IT software necessary for its proper functioning, intended by the manufacturer to be used in humans for the purpose of diagnosis, prevention, monitoring, treatment or alleviation of disease; diagnosis, monitoring, treatment, alleviation or compensation for an injury or handicap; investigation, replacement or modification of an anatomical or physiological process; of intervention in conception, for which the product does not exert its principal action in or on the human body for which it is intended, by pharmacological, immunological or metabolic means, but whose function may be assisted by such means.

Medical devices are classified into four classes according to the increasing complexity and risk.

• Class I:
  Less critical medical devices, such as the large majority of non-active and non-invasive ones. Within this class it is possible to identify two subclasses: sterile class I (medical devices in a sterile state) and class I m (devices that perform a measurement function)
• Class II a:
  Medium risk medical devices, such as certain non-active devices (invasive and non- invasive) and active devices that interact with the body in a non-hazardous manner.
• Class II b:
  Medium/high risk medical devices, some devices such as non-active (invasive types) and active devices that interact with the body in a dangerous manner.
• Class III:
  High-risk medical devices, such as most of those implantable devices or those containing medicines or animal derivatives, and some devices that work on the functions of vital organs.

CE compliance

It is an indication of conformity with the essential safety requirements laid down by one or more EU Directives applicable to the product. This certifies that the product has been subjected to conformity assessment procedures, which differ depending on the product category and the relevant directive. A CE marked product can then be marketed and used throughout the Community.

The certificate for CE compliance for Class I medical devices is issued by the accredited Notified Body for the certification of specific types of medical devices and specific marking procedures. The manufacturer may apply to any accredited Notified Body in Italy or another EU country, at his discretion.