Chosen class: III

• Is your device INVASIVE or NON-INVASIVE?

  You answered: Invasive

• Is it NON-SURGICALLY INVASIVE or SURGICALLY INVASIVE?

  You answered: Surgically invasive

• What is the time length of its use?

  You answered: Implantable or long term (more than 30 days)

• Is it intended to be placed in the teeth?

  You answered: No

• Is it intended for use in direct contact with the heart or central circulatory system or the central nervous system?

  You answered: Yes

• Is it intended to have a biological effect or be wholly or mainly absorbed?

  You answered: Yes

• Is it intended to undergo chemical change in the body?

  You answered: No

• Is it intended to administer medicines?

  You answered: No

• Is it an active implantable device or its accessory?

  You answered: Yes

• Is it a breast implant?

  You answered: No

• Is it a surgical mesh?

  You answered: Yes

• Is it a total or partial joint replacement?

  You answered: No

• Is it an ancillary component of a total or partial joint replacement such as screws, wedges, plates and instruments?

  You answered: No

• Is it a spinal disc replacement implant?

  You answered: No

• Is it an implantable device that come into contact with the spinal column?

  You answered: No

• Is it an ancillary component of a spinal disc replacement or other device that comes in contact with the spinal column such as screws, wedges, plates and instruments?

  You answered: No

• Is your device ACTIVE?

  You answered: No

• Does your device incorporate a medicinal product with an ancillary function?

  You answered: No

• Is it used for contraception or prevention of the transmission of sexually transmitted diseases?

  You answered: No

• Is it intended specifically to be used for disinfecting, cleaning, rinsing or, where appropriate, hydrating contact lenses?

  You answered: No

• Is it intended specifically to be used for disinfecting or sterilising medical devices that are not contact lenses ? NOTE: If it is only intended for cleaning and only by physical action, this rule does not apply.

  You answered: No

• Is it manufactured utilizing tissues or cells of human or animal origin, or their derivatives, which are non-viable or rendered non-viable?

  You answered: No

• Does it incorporate or contain nanomaterials?

  You answered: Yes

• What is the potential for internal exposure?

  You answered: High or medium

• Is it intended to administer medicinal products by inhalation, being an invasive device with respect to body orifices, other than surgically invasive devices?

  You answered: No

• Is it composed of substances or of combinations of substances that are intended to be introduced into the human body via a body orifice or applied to the skin and that are absorbed by or locally dispersed in the human body?

  You answered: No

• Is it an active therapeutic device with an integrated or incorporated diagnostic function that includes an integrated or incorporated diagnostic function which significantly determines the patient management by the device (example: closed loop systems or automated external defibrillators)?

  You answered: No