Is your device Implantable or Surgically Invasive?
Surgically invasive device means:
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an invasive device which penetrates inside the body through the surface of the body, including through mucous membranes of body orifices with the aid or in the context of a surgical operation; and
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a device which produces penetration other than through a body orifice.
Is the device intended specifically for use in direct contact with the heart, central circulatory system or the central nervous system?
Central circulatory system means the following blood vessels: arteriae pulmonales, aorta ascendens, arcus aortae, aorta descendens to the bifurcatio aortae, arteriae coronariae, arteria carotis communis, arteria carotis externa, arteria carotis interna, arteriae cerebrales, truncus brachiocephalicus, venae cordis, venae pulmonales, vena cava superior and vena cava inferior.
Central nervous system means the brain, meninges and spinal cord.
Is the device an active implantable device or its accessories?
OR
Is the device a breast implant or surgical mesh?
Does the device have a biological effect or is it wholly or mainly absorbed?
Is the device intended to be used transiently?
Is the device intended to be used as a total or partial joint replacement?
OR
Is the device intended to be used as a spinal disc replacement implant or an implantable device that comes into contact with the spinal column?
Is the device intended to be used as an ancillary component such as a screw, wedge, plate and instrument?
Is the device intended to be used to undergo chemical change in the body ?
Chemical reaction, a process in which one or more substances, the reactants, are converted to one or more different substances, the products. Substances are either chemical elements or compounds. A chemical reaction rearranges the constituent atoms of the reactants to create different substances as products. combustion.
Is the device intended for long-term use?
Is the device intended to be used long term and placed in the teeth?
Is the device intended to be used short-term and placed in teeth?
Is the device intended to supply energy in the form of ionising radiation ?
Is the device intended to administer medicinal products ?
Directive 2001/83/EC, Article 1:
Point 2
Medicinal product
(a) Any substance or combination of substances presented as having properties for treating or preventing disease in human beings; or
(b) Any substance or combination of substances which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis.
Point 10
Medicinal products derived from human blood or human plasma: Medicinal products based on blood constituents which are prepared industrially by public or private establishments, such medicinal products including, in particular, albumin, coagulating factors and immunoglobulins of human origin.
How long shall the device be used?
Is such an administration of a medicinal product (by means of a delivery system) done in a manner that is potentially hazardous taking account of the mode of application?
Directive 2001/83/EC, Article 1:
Point 2
Medicinal product
(a) Any substance or combination of substances presented as having properties for treating or preventing disease in human beings; or
(b) Any substance or combination of substances which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis.
Point 10
Medicinal products derived from human blood or human plasma: Medicinal products based on blood constituents which are prepared industrially by public or private establishments, such medicinal products including, in particular, albumin, coagulating factors and immunoglobulins of human origin.
Is the device implantable and/or a long-term surgically invasive devices and intended to be placed in the teeth?
Is the device a reusable surgical instrument, intended for transient use?
A reusable surgical instrument means an instrument intended for surgical use in cutting, drilling, sawing, scratching, scraping, clamping, retracting, clipping or similar procedures, without a connection to an active device and which is intended by the manufacturer to be reused after appropriate procedures such as cleaning, disinfection and sterilisation have been carried out.
Transient means normally intended for continuous use for less than 60 minutes.
Other implantable or surgically invasive device intended for long-term use?
Other surgically invasive device intended for transient or short-term use?
