European Medical devices Magazine

SMTONLINE Kimball s Ferris Explains Importance of Facility Location

SUMMARY This Directive applies to medical devices * and accessories * .

It does not apply to:

  • the devices for in vitro diagnosis ;
  • to active implantable devices ;
  • to medicinal products for human use , including blood derivatives;
  • with cosmetics ;
  • partially human blood , the 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 blood cells in the exception of devices referred to in paragraph 4a;
  • organs, tissues and cells of human origin nor to products incorporating tissues or cells of human origin, or derived, with the exception of devices referred to in paragraph 4a;
  • organs, tissues and cells of animal origin except for the manufacture of a device, an animal tissue rendered non-viable or derivatives of animal tissues using non-viable products;

Essential requirements

Medical devices must not compromise the clinical condition or the safety of patients. They must also not present any risk to the persons implanting them, or to third parties.

These devices are required to achieve the performance specified by the manufacturer. They must be designed so that they can withstand the conditions of storage and transport.

Harmonized standards

Member States are required to publish their national standards implementing the relevant harmonized standards also includes the monographs of the European Pharmacopoeia.

Member States shall presume the devices meet the essential requirements laid down in this Directive when such devices meet national standards transposing harmonized standards already existing in the field.

Compliance Procedures

Any device will be subject to a conformity assessment procedure. Member States shall designate independent agencies contributing to the implementation of these procedures for devices other than those representing minimal risk.

Placing on the market and free movement

Member States shall take the necessary measures to ensure that devices may be placed on the market and put into service only if they meet the requirements of this Directive and does not endanger the health and safety of patients, users and third parties when properly installed, maintained and used for their intended purpose.

Member States shall not impede the placing on the market, free movement and establishment commissioning devices meet the essential safety requirements set out in the Annexes to the Directive and bears the marking " CE ".

European database

The purpose of the European database is to store regulatory data. These are made available to the competent authorities and contain information relating to:

  • the registration of manufacturers;
  • Data certificates issued, modified, suspended, withdrawn or refused;
  • Data obtained under the vigilance procedure;
  • data on clinical investigations.

Vigilance

The manufacturer shall inform, as soon as he is aware, the competent authorities of incidents resulting in death or deterioration of the health status of the patient in accordance with the procedures of a system of technical vigilance. This information must be recorded and evaluated by the Member States.

Watch

Notified bodies are authorized to perform inspections of manufacturers. For their part, manufacturers are required to provide inspectors with all relevant information.

European Medical Device Technology
Magazine (Ubm Canon)
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

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  • Avatar eric b How do you stop from having a erection and how do you increase the size of your penis?
    May 05, 2008 by eric b | Posted in Men's Health
    • There is no way to increase the size of a penis. There are no medications that have ever been shown to do this, and there is no surgery that will make it longer (it actually usually makes it a little shorter). Keeping your pubic hair closely trimmed or shaved will make it look bigger, and a tight ring placed around the base of the shaft while erect will help give your erection more tumescence, but it will not be bigger. As far as how not to get an erection - think of your grandmother naked on a cold day or something.