Glossary

Active device (European Union)
[1] Any medical device operation which depends on a source of electrical energy or any source of power other than that directly generated by the human body or gravity and which acts by converting this energy. Medical devices intended to transmit energy, substances or other elements between an active medical device and the patient, without any significant change are not considered to be active medical devices [Directive 93/42/EEC1].
[2] Device that operates on and converts a source of energy in order for it to be able to achieve its intended treatment.


Active device for diagnosis (European Union)
Active medical device, whether used alone or in combination with other medical devices, to supply information for detecting, diagnosing, monitoring or treating physiological conditions, states of health, illness or congenital deformities [Directive 93/42/EEC].


Active therapeutic device(European Union)
Active medical device, whether used alone or in combination with other medical devices, to support, modify, replace or restore functions or structures with a view to treatment or alleviation of an illness, injury or handicap [Directive 93/42/EEC].


Artificial classification
Classification based on factual mutual properties or phenomenal properties like appearance.


Body orifice (European Union)
Natural opening, as well as the external surface of the eyeball, or any permanent artificial opening, such as a stoma [Directive 93/42/EEC].


Breached dermis
Perforation or other physical penetration of epidermis revealing dermis.


Central circulatory system (European Union)
arteriae pulmonales, aorta ascendens, arcus aorta, 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, vena cava inferior [Directive 93/42/EEC].


Classification
[5] The placement of medical devices into primary and sub-classes for regulatory control.


Classification rules
[1] Rules enabling proper classification of an item.


Conformity Assessment Procedure
Formal series of steps undertaken to fulfil relevant requirements for placing a product on the market with the CE Marking of conformity according to the applicable Directive.


Duration of Contact
Period of continuous use of a medical device on a patient normally intended by the Manufacturer. [Council Directive 93/42/EEC]


Illness
Disease, sickness or ailment.


Implantable device
Device which is intended to be totally introduced into the human body or to replace an epithelial surface or the surface of the eye by surgical intervention which is intended to remain in place after the procedure [Directive 93/42/EEC].


Implementing rules
Rules governing application of a given classification scheme, sometimes incorporating anti-selection prevention criteria.


Intended purpose
[1] Purpose of a medical device specified by a manufacturer (or his legal representative as manufacturer) but not determinative.
[2] Use for which the device is intended (sic) according to the data supplied by the manufacturer on the labelling, in the instructions and/or in promotional material [Directive 93/42/EEC (as amended)]


Invasive device (European Union)
Device which, in whole or in part, penetrates inside the body, either through a body orifice or through the surface of the body [Directive 93/42/EEC].


Long-term
Normally intended for continuous use for more than 30 days [Directive 93/42/EEC].


Manufacturer
[1] The natural or legal person with responsibility for design, manufacture, packaging and labelling of a device before it is placed on the market under his own name regardless of whether these operations are carried out by that person himself or on his behalf by a Third Party. [Article 1(f) Council Directive 93/42/EEC (as Amended)]
[2] A person responsible for design, manufacture, packaging and labelling and places the device on the market under his own name, is also the manufacturer


Mode of Action
The (most significant or important) use to which the device is (indicatively) intended according to the (scientific) data (regarding mechanism of action) supplied by the Manufacturer on the labelling, the instructions for use and/or the promotional materials (taking into account the way the product is presented) (and determined by prevailing scientific data)


Mode of Contact
Way in which the medical device is introduced into the body and how left in the body, as necessary.


Product Class
Term used synonymously for EC Product Class [Council Directive 93/42/EEC]


Product Name
Commercial or brand name of a medical device


Short-term
Normally intended for continuous use for not more than 30 days [Directive 93/42/EEC].


Special rules
Rules devised to prevent anti-selection of property space thereby ensuring determination and assignment of item to correct class. Surgically invasive (European Union) Invasive device which penetrates inside the body through the surface of the body, with the aid or in the context of a surgical operation [Directive 93/42/EEC].


Transient (European Union)
Normally intended for continuous use for less than 60 minutes [Directive 93/42/EEC].