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MDSS would like to provide clients with an overview of frequent
terminology used during Conformity Assessment Procedure(s). Without this very basic
knowledge, it will be almost impossible to classify devices and ascertain the best route
to take for CE certification.
Accessory
'accessory' means an article which, whilst not being a device,
is intended specifically by its manufacturer to be used together with a device to enable
it to be used in accordance with the use of the device intended by the manufacturer of the
device;
Active device for diagnosis
Any 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, illnesses or congenital deformities.
Active medical device
Any medical device operation of 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 he active medical devices.
Active therapeutical device
Any active medical device, whether used alone or in combination
with other medical devices, to support, modify, replace or restore biological functions or
structures with a view to treatment or alleviation of an illness, injury or handicap.
Body orifice
Any natural opening in the body, as well as the external surface
of the eyeball, or any permanent artificial opening, such as a stoma.
Central circulatory system
For the purposes of this Directive, 'central circulatory system'
means the following vessels. Arteriae pulmonales, aorta ascendens, arteriae coronariae,
arteries carotis communis, arteries carotis externa, arteries carotis interna, arteriae
cerebrates, truncus brachicephalicits, venae cordis, venae pulmonales, vena cava superior,
vena cava inferior.
Central nervous system
For the purposes of this Directive, 'central nervous system'
means brain, meninges and spinal cord.
Custom-made device
'custom-made device' means any device specifically made in
accordance with a duly qualified medical practitioner's written prescription which gives,
under his responsibility, specific design characteristics and is intended for the sole use
of a particular patient.
- The above mentioned prescription may also be made out by any other
person authorised by virtue of his professional qualifications to do so.
- Mass-produced devices which need to be adapted to meet the specific
requirements of the medical practitioner or any other professional user are not considered
to be custom-made devices;
Devices intended for clinical investigation
'device intended for clinical investigation' means any device
intended for use by a duly qualified medical practitioner when conducting investigations
as referred to in Section 2.1 of Annex X in an adequate human clinical environment.
- For the purpose of conducting clinical investigation, any other
person who, by virtue of his professional qualifications, is authorised to carry out such
investigation shall be accepted as equivalent to a duly qualified medical practitioner;
Device used for in vitro diagnosis
'device used for in vitro diagnosis’ means any device which
is a reagent, reagent product, kit, instrument, equipment or system, whether used alone or
in combination, intended by the manufacturer to be used in vitro for the examination of
samples derived from the human body with a view to providing information on the
physiological state, state of health or disease, or congenital abnormality thereof;
Implantable device
Any 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.
- Any device intended to be partially introduced into the human body
through surgical intervention . and intended to remain in place after the procedure for at
least 30 days is also considered an implantable device.
(also see Surgically Invasive Device)
Intended purpose
'intended purpose' means the use for which the device is
intended according to the data supplied by the manufacturer on the
labeling, in the
instructions and/or in promotional materials;
Invasive device
A device which, in whole or in part, penetrates inside the body,
either through a body orifice or through the surface of the body. (also see Surgically Invasive Device)
Long term
Normally, intended for continuous use for more than 30 days.
Manufacturer
'manufacturer' means the natural or legal person with
responsibility for the 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.
- The obligations of this Directive to be met by manufacturers also
apply to the natural or legal person who assembles, packages, processes, fully refurbishes
and/or labels one or more ready-made products and/or assigns to them their intended
purpose as a device with a view to their being placed on the market under his own name.
This subparagraph does not apply to the person who, while not a manufacturer within the
meaning of the first subparagraph, assembles or adapts devices already on the market to
their intended purpose for an individual patient;
Medical Device
'medical device' means any instrument, apparatus, appliance, material or other
article, whether used alone or in combination, including the software necessary for its
proper application intended by the manufacturer to be used for human beings for the
purpose of:
- diagnosis, prevention, monitoring, treatment Or alleviation of
disease,
- diagnosis, monitoring, treatment, alleviation of or compensation for
an injury or handicap,
- investigation, replacement or modification of the anatomy or of a
physiological process,
- control of conception,
- and which does not achieve its principal intended action in or on the
human body by pharmacological, immunological or metabolic means, but which may be assisted
in its function by such means;
Placing on the market
'placing on the market' means the first making available in
return for payment or free of charge of a device other than a device intended for clinical
investigation, with a view to distribution and/or use on the Community market, regardless
of whether it is new or fully refurbished;
Putting into service
'putting into service' means the stage at which a device is
ready for use on the Community market for the first time for its intended purpose.
Reusable surgical instrument
Instrument intended for surgical use by cutting, drilling,
sawing, scratching, scraping, clamping, retracting, clipping or similar procedures,
without connection to any active medical device and which can be reused after appropriate
procedures have been carried out.
Short term
Normally intended for continuous use for not more than 30 days.
Surgically invasive device
An invasive device which penetrates inside the body through the
surface of the body, with the aid or in the context of a surgical operation.
- For the purposes of this Directive devices other than those referred
to in the previous subparagraph and which produce penetration other than through an
established body orifice, shall be treated as surgically invasive devices
Transient
Normally intended for continuous use for less than 60 minutes.
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