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Active implantable medical devices











Entry into force: : 01/01/1993



RD 634/1993.
RD 1143/2007 (Amendment RD 634/1993)
RD 1616/2009



 This Directive shall apply to:

  1. Active implantable medical devices.
  2. The conditions for the use of active implantable medical devices in clinical research.
  • 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:
    1. diagnosis, prevention, monitoring, treatment or alleviation of disease.
    2. diagnosis, monitoring, treatment, alleviation of or compensation for an injury or
    3. investigation, replacement or modification of the anatomy or of a physiological
    4. control of conception.
  • 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.
  • 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.
  • 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.
  • 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).



This Directive shall not apply to:

  1. 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;
  2. 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.
  3. 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.
  4. 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