European Medical devices guidance

Europe's economic development level is higher than the continents, the medical device market is relatively mature and relatively speaking, with the exception of Albania, Bulgaria, and a few other countries, other European countries, good industrial foundation, hospital equipment level is higher. Europe is not only medical device industry is well developed, but also the world's leading medical device market. According to foreign data show that in 2010, the global medical device market, total sales of approximately € 184.9 billion (equivalent to more than 2300 billion U.S. dollars), of which Europe accounted for about 30 percent to 55.3 billion euros, is second only to the U.S. global The second largest medical device market. Germany, France, Britain, Italy and Switzerland, the European medical device markets together accounted for 76% of the medical device market, while other European countries, the total market for medical devices only the remaining 1/4 share. This reflects the European medical device market highly intensive.

CE certification is a stepping stone

China currently many domestic medical device manufacturers have products into the European market will, but most domestic manufacturers on the situation in Europe is poorly understood.

Depending on the medical devices segment, the EU has successively issued three directives on medical devices, in order to coordinate the European medical device product management practices. The world's medical device manufacturers want their products into the European market must comply with the above requirements. This three related medical device products access instructions are: Active Implantable Medical Devices Directive (AIMDD, 90/335/EEC), the Medical Device Directive (MDD,

93/42/EEC) and IVD Directive (IVDD, 98/79EEC).

In the above three instructions, with the first two directives (MDD) the widest range of application, including almost all the country's exports of medical products, such as sanitary materials and medical dressings, medical catheters, ventilators, various endoscopic mirrors and patient monitors and so on.

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CreateSpace Independent Publishing Platform Devine Guidance for Complying with the European Medical Device Directive (MDD): The MDD 93/42/EEC
Book (CreateSpace Independent Publishing Platform)
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'
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

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.. 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.

European Union (EU) Medical Device Directive (MDD) Changes: Industry Impact Analysis
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Medical Device Vigilance/Monitoring: European Device Directives Compliance
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Ce Marking for Medical Devices: A Handbook to the Medical Devices Directives : Medical Devices Directive 93/42/Eec : The Active Implantable Medical Devices Directive 90/396/Eec
Book (Ieee)

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