Legislation
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Modifications
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Date
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93/42/CEE
93/68/CEE
2007/47/CE
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Entry into force: : 01/01/1993
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Transposition
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RD 634/1993.
RD 1143/2007 (Amendment RD 634/1993)
RD 1616/2009
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This Directive shall apply to:
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Active implantable medical devices.
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The conditions for the use of active implantable medical devices in clinical research.
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Medical device: Any instrument, apparatus, appliance, material or other article,
whether used alone or in combination, together with any accessories or software
for its proper functioning, intended by the manufacturer to be used for human beings
in the:
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diagnosis, prevention, monitoring, treatment or alleviation of disease.
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diagnosis, monitoring, treatment, alleviation of or compensation for an injury or
handicap.
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investigation, replacement or modification of the anatomy or of a physiological
process.
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control of conception.
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Active medical device: any medical device relying for its functioning on a source of
electrical energy or any source of power other than that directly generated by the human
body or gravity.
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Active implantable medical device: any active medical device which is intended to be totally or
partially introduced, surgically or medically, into the human body or by medical intervention
into a natural orifice, and which is intended to remain after the procedure.
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Custom-made device: any active implantable medical device specifically made in accordance
with a medical specialist's written prescription which gives, under his responsibility, specific
design characteristics and is intended to be used only for an individual named patient.
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Device intended for clinical investigation: Any active implantable medical device intended for
use by a specialist doctor when conducting investigations in an adequate human clinical
environment (anex 7.2.1).
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Exceptions
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This Directive shall not apply to:
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Medicinal products covered by Directive 2001/83/EC. In deciding whether a product falls
under that Directive or this Directive, particular account shall be taken of the principal
mode of action of the product;.
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Human blood, blood products, plasma or blood cells of human origin or to devices which
incorporate at the time of placing on the market such blood products, plasma or cells,
with the exception of devices referred to in paragraph 5.
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Transplants or tissues or cells of human origin nor to products incorporating or derived
from tissues or cells of human origin, with the exception of devices referred to in
paragraph 5.
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Transplants or tissues or cells of animal origin, unless a device is manufactured utilizing
animal tissue which is rendered non-viable or non-viable products derived from animal
tissue.
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