European medical devices definition

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A medical device is an instrument, appliance, implant, in vitro reagent, or similar or related article that is used to diagnose, prevent, or treat disease or other conditions, and do not achieve their purposes through chemical action within or on the body. Whereas medicinal products achieve their principal action by pharmacological, immunological or metabolic, medical devices act by other means like physical, mechanical, or thermal. Medical devices vary widely in complexity and application. Examples range from the simplest, such as tongue depressors, medical thermometers and disposable gloves to advanced devices such as implantable microchips, biochemical tests, medical robots, cardiac pacemakers and neuroprothesis. The design of medical devices is an important segment of the field of biomedical engineering.

The global medical device market reached about $ 209 billion U.S. in 2006.

Definitions

Legal framework of the European Union and the definition

Based on the new approach, the rules that relate to the safety and performance of medical devices were harmonized across the EU in the 1990s. The new approach, which is defined in a European Council Resolution of May 1985, represents an innovative way of technical harmonization. It aims to remove technical barriers to trade and dispel the consequent uncertainty for economic operators, to facilitate the free movement of goods within the EU.

The basic legal framework consists of three directives:

  • Directive 90/385/EEC on active implantable medical devices
  • Directive 93/42/EEC on medical devices
  • Directive 98/79/EC on in vitro diagnostic

It aims to ensure a high level of protection of human health and safety and proper functioning of the single market. These three main directives have been supplemented over time by several modifying and implementing directives, including the last technical revision brought about by Directive 2007/47 EC.

Directive 2007/47/EC defines a medical device as any instrument, apparatus, appliance, software, material or other article that is used alone or in combination, including the software specifically for diagnostic or therapeutic purposes, which the manufacturer has the intended for use in human beings. Such devices are used to:

  • Diagnosis, prevention, monitoring, treatment or alleviation of disease
  • Diagnosis, monitoring, treatment, alleviation or compensation for an injury or handicap
  • Investigation, replacement or modification of the anatomy or of a physiological process
  • Conception control

This includes devices that do not achieve their principal intended action in or on the human body by pharmacological, immunological or metabolic means, but may be assisted in his duties by the media.

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2005-04-04 22:03:48 by -

Not a lap band survivor here, but

It still has a lot of dangers and complications. Here's an online article (5 years old):
FDA panel refuses to endorse obesity 'Lap-Band'
device
The Lap-Band device
June 19, 2000
Web posted at: 8:45 PM EDT (0045 GMT)
WASHINGTON (CNN) -- A government advisory committee refused to give its seal of approval Monday to a weight-control device that's been used in Europe for seven years - - but has run into medical difficulties during its U.S. trials.
By a 6-4 vote, the Food and Drug Administration advisory committee concluded there was insufficient data to determine whether the device, called Lap-Band, was safe and effective

2003-10-02 06:38:37 by apathetichuman

Sorry for the delay

Had to sleep. Okay, not what you asked for, but, along the same lines. I will find the cream connection and post it later. These articles are all about the companies that pay lots of money for foreskin harvesting. Granted, some of their discoveries are for the betterment of medicine. However, they are all motivated by foreskin for money.
Don't believe it ? Read for yourself - directly from the companies involved - all about the massive foreskin-for-sale industry !
Periscope: Bionic Band-Aid
Newsweek Wednesday, January 13, 1999
Living Human Skin Equivalent Apligraf
Molecule of the Month February 1998
Bioengineered skin wins approval from the FDA
Wound Care newsletter July 1998
The Role of Tissue Engineering in Wound Care
AVF Newsletter American Venous...

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See the Future Development of the Medical Device Industry at MDiT Forum and ..  — MarketWatch
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ITC Launches New Patent Probe Of Sleep Aid Devices  — Law360
.. has voted to launch an investigation of breathing masks and other equipment used to treat sleep disorders following allegations of patent infringement last month by California-based ResMed Inc. against Chinese medical device giant BMC Medical Co.


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