Application of the Active Implantable Medical Device Directive
(5 September 2007)
Article 1
1. This Directive shall apply to active implantable medical devices.
2. For the purposes of this Directive, the following definitions shall apply:
(a) ‘medical device’ means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, together with any accessories, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:
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;
(b) ‘active medical device’ means 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;
(c) ‘active implantable medical device’ means 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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3. Where an active implantable medical device is intended to administer a substance defined as a medicinal product within the meaning of Article 1 of Directive 2001/83/EC, that device shall be governed by this Directive, without prejudice to the provisions of Directive 2001/83/EC with regard to the medicinal product.
4. Where an active implantable medical device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product within the meaning of Article 1 of Directive 2001/83/EC and which is liable to act upon the human body with action that is ancillary to that of the device, that device shall be evaluated and authorised in accordance with this Directive.
4a. Where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product constituent or a medicinal product derived from human blood or human plasma within the meaning of Article 1 of Directive 2001/83/EC and which is liable to act upon the human body with action that is ancillary to that of the device, hereinafter referred to as a ‘human blood derivative’, that device shall be assessed and authorised in accordance with this Directive.
5. This Directive constitutes a specific Directive within the meaning of Article 1(4) of Directive 2004/108/EC.
6. This Directive shall not apply to:
(a) 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;
(b) 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 4a;
(c) transplants or tissues or cells of human origin or to products incorporating or derived from tissues or cells of human origin, with the exception of devices referred to in paragraph 4a;
(d) transplants or tissues or cells of animal origin, unless a device is manufactured utilising animal tissue which is rendered non-viable or non-viable products derived from animal tissue.
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