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Active implantable medical devices directive

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  Directive

Active implantable medical devices Directive (90/385/EEC)

  Scope

This Directive shall apply to active implantable medical devices

EXCLUSIONS

This Directive shall not apply to:

  • 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;
  • 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;
  • 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;
  • 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.

DEFINITIONS

For the purposes of this Directive, the following definitions shall apply:

  • ‘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:
    • 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;
  • ‘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;

  Description

The Active Implantable Medical Device (AIMD) Directive 90/385/EEC defines an active implantable medical device as "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". As one of the highest risk categories of device, they are subject to rigorous regulatory controls both pre- and post-market. The regulatory controls set out in the AIMD Directive also apply to any accessories that are used to enable the device to operate as intended, for examples leads, programmers, controllers, battery packs, software applications, implant kits and refill kits.

  Harmonised standards

EN 556-1:2001 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
EN 556-1:2001/AC:2006 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
EN 556-2:2015 Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE" - Part 2: Requirements for aseptically processed medical devices
EN 1041:2008 Information supplied by the manufacturer of medical devices
EN ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009)
EN ISO 10993-1:2009/AC:2010 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009)
EN ISO 10993-3:2014 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014)
EN ISO 10993-4:2009 Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2002, including Amd 1:2006)
EN ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)
EN ISO 10993-6:2009 Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2007)
Show all the standards...
EN 556-1:2001
Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Par...
EN 556-1:2001/AC:2006
Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Par...
EN 556-2:2015
Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE" - Pa...
EN 1041:2008
Information supplied by the manufacturer of medical devices
EN ISO 10993-1:2009
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management p...
EN ISO 10993-1:2009/AC:2010
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management p...
EN ISO 10993-3:2014
Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and repro...
EN ISO 10993-4:2009
Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (I...
EN ISO 10993-5:2009
Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009...
EN ISO 10993-6:2009
Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 1...
Show all the standards...

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