European Medical Device Directory

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Terms of marketing - The main principles of the CE marking

A product that meets the definition of a medical device (DM) must be CE marked under the European Directive 93/42/EEC. Other guidelines exist for active implantable medical devices (Directive 90/385/EEC) and medical devices in vitro diagnostic (Directive 98/79/EC). To be placed on the market must have a DM met the requirements of the European Directive. The European Directive describes the requirements for safety and performance, as well as how to put on the market that require manufacturers.
DM are divided into four classes (Class I, IIa, IIb, III) risk according to rules laid down in the Directive and hazard criteria.
Whatever the class of risk, safety requirements and performance are the same.
The risk class determines how to market, which are reinforced more risk class is high.
All DM must be a CE certificate issued by a third party (notified body) with the exception of DM lower risk (class I).
The manufacturer must affix the CE marking on the products it certifies after verifying product conformity with the requirements of the European Directive.
CE marked a DM can be placed on the market in all the countries of the European Union.
All DM are subject to a risk analysis and clinical evaluation.
The manufacturer shall establish a system for managing incidents and potential incidents which are transmitted by particular users of its MD.

Essential requirements

When a product falls within the scope of a directive under the New Approach Directives such as medical devices, it is mandatory to meet the essential requirements to be placed on the market.

The essential requirements are of two types: general requirements applicable to all devices and requirements for the design and construction that may or may not be applicable depending on the characteristics of the device.

Compliance with the essential requirements can be demonstrated by the application of harmonized standards give presumption of conformity with the essential requirements to which they relate or by other means subject to prove that it can meet the essential requirements.

The CE Mark is a visual symbol that indicates conformity of medical devices with the essential requirements applicable to them.

Classification

Classification of medical devices intended to assign a risk level to each medical device to assign valuation rules and proportional to the level of risk control.

Classification of medical devices based on a share of general rules based on the characteristics of each medical device (duration of use, whether or not reuse, the invasive nature of the device or not, therapeutic or diagnostic purposes) and secondly on specific rules for certain families of medical devices.

If several rules apply to the classification used is the highest.

It exists to this day, 18 classification rules, which allows the manufacturer to determine the risk class of the medical device.

Class I includes:

  • Non-invasive devices,
  • reusable surgical instruments,
  • devices in contact with injured or used as a mechanical barrier to the compression or absorption of exudates skin ...

Examples of medical devices Class I: wheelchairs, bandages, scalpels ...

Class IIa includes:

  • diagnostic tools,
  • devices intended for channeling or storing blood, body fluids or tissues,
  • invasive devices surgically ...

Directory of the European Medical Device & Biomaterials Industry
Book (Elsevier Science Pub Co)
2006-04-15 20:34:56 by merrimac

No it doesn't there is accurate non Lab versions

Cholestech LDX System, which carries the CE Mark for marketing of medical devices in the European Union, has been certified
by the United States Cholesterol Reference Method Laboratory Network (CRMLN), which validates that the system meets the gold standard for accuracy and reproducibility developed by the Centers for Disease Control and Prevention (CDC) for the measurement of total cholesterol and HDL cholesterol consistent with National Cholesterol Education Program (NCEP) analytical goals. The NCEP recommends that everyone over the age of 20, or more than 200 million Americans, should be screened for cholesterol.

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