Is your device active and intended to administer and/or remove medicinal products, body liquids or other substances to or from the body?
Medicinal Product is any substance or combination of
substances presented for treating or preventing disease in human beings or in animals.
Any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in human beings or animals is likewise considered a medicinal product.
Is this done in a manner that is potentially hazardous, taking account of the nature of the substances involved, of the part of the body concerned and of the mode of application?
Medicinal Product is any substance or combination of
substances presented for treating or preventing disease in human beings or in animals.
Any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in human beings or animals is likewise considered a medicinal product.