Chosen class: IIb

  • Is your device INVASIVE or NON-INVASIVE?

    You answered: Non-invasive

  • Is it intended for channelling or storing blood, body liquids, cells or tissues, liquids or gases for the purpose of eventual infusion, administration or introduction into the body?

    You answered: No

  • Is your device ACTIVE?

    You answered: Yes

  • Is it therapeutic?

    You answered: No

  • Is it intended to control or monitor the performance of active therapeutic class IIb devices, or intended directly to influence the performance of such devices?

    You answered: No

  • Is it intended for controlling, monitoring or directly influencing the performance of active implantable devices?

    You answered: No

  • Is it intended for diagnosis and monitoring?

    You answered: Yes

  • Is it intended to supply energy which will be absorbed by the human body?

    You answered: No

  • Is it intended to allow direct diagnosis or monitoring of vital physiological processes?

    You answered: No

  • Is it intended to emit ionizing radiation for diagnostics?

    You answered: No

  • Is it a software?

    You answered: Yes

  • Is it intended to provide information which is used to take decisions with diagnosis or therapeutic purposes?

    You answered: Yes

  • Does such a device have a significant impact?

    You answered: Yes, an impact that may cause a serious deterioration of a person's state of health or a surgical intervention.

  • Is it intended to monitor physiological processes?

    You answered: No

  • Is it intended to administer and/or remove medicinal products, body liquids or other substances to or from the body?

    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: No

  • 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