European CE Mark Medical Devices

CE marking for medical devices

Medical devices (MD) are a group of very different products, ranging from consumables to large equipment: syringe, stethoscope, catheter, MRI (magnetic resonance imaging), ...
Used both to diagnose disease (diagnosis), prevent its occurrence (prevention) or treatment effects (therapy), medical devices occupy an increasingly important role in the health sector.
To move freely within the European Economic Area (EEA), medical devices must bear the marking CE marking.
DEKRA Certification, a key player in the medical field, you in your process of fostering the quality and security of your medical products through product certification according to the CE marking.
DEKRA Certification also allows you to combine the certification of your management system ISO 13485 certification with the CE marking your products.

What is CE marking?

The CE marking (marking European Community) a medical device (DM) means that the DM is consistent with legal requirements of the EU directives on health and safety.
The company must demonstrate that the product complies with the requirements of quality and safety.
She enjoys the CE marking.
The latter, once affixed, allows the placing on the market of the medical device in all members of the European Union and the European Economic Area states.
There is a mutual recognition of harmonized between Member States legislation.
The CE marking is mandatory for all marketing:
- From 1 January 1995 on active implantable medical devices (AIMD).
- Since 14 June 1998 on the other DM. What are the benefits of CE marking?

Have the CE mark on your medical products will bring many benefits:

  • CE Marking on a product is a sign for governments that the product complies with the requirements of quality and safety can be legally sold within the European Union as well as European Free Trade Agreement.
  • It allows free movement of the product within the European single market.
  • It is the guarantee for customers of a product complies with safety standards, and guarantee of quality.
  • It adds credibility to the product, which helps to increase sales and customer satisfaction.
Who is affected?

Distributors and manufacturers of medical devices and their subcontractors

6 Steps to get your CE:
  1. Definition of the devices concerned and their class as well as guidelines to follow

  2. Choosing a certified body (except for medical devices class self-certification)

  3. Definition of the evaluation process for compliance

  4. Definition of the technical file

  5. CE marking

  6. Marketing

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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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