Medical devices European Directives


Make sure your in vitro diagnostic (IVD) devices through SGS authentication and audit access to 98/79/EC IVD CE mark, safe, legal, and quickly enter the market.

For in vitro diagnostic medical devices Directive 98/79/EC for the EU market, the European Free Trade Area (EFTA), Switzerland, Turkey and others who wish to join the European Union countries / regions all manufacturers of products sold legal requirements. In some parts of the world, this is a contractual requirements IVD Directive.

According to Directive 98/79/EC, SGS United Kingdom is "Notified Body 0120." According to the instructions, we have a full range of indicators, for example, all List A.List B and Self-test in vitro diagnostic equipment. Whether your company or production is located, we have established a global network of local offices are able to ensure that you get 98/79/EC effectively and efficiently verified.

The following authentication options IVD Directive contains technical documents, including field audits and / or assessment of Appendix III, IV and VII. Our on-site audits to assess compliance with ISO 13485:2003 and usually Directive 98/79/EC compliance.

In Europe, Asia and North and South America, we have a professional inspector IVDD network to support existing IVD services. Therefore, we can provide you with audits help to ensure global regions (including North America, Europe and Asia-Pacific) marketing product, you verify compliance with approved regulatory responsibilities that you should follow.

SGS audit conducted in accordance with Directive 98/79/EC, for you to get the CE mark and enter the European IVD market support.

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Nonwoven medical disposables. (demand for nonwoven medical disposables)(includes related article on the European market for disposable medical supplies): An article from: Nonwovens Industry
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2007-01-15 22:44:28 by --

We are.

The U.S. relies heavily on the African Continent for petroleum and strategic minerals. In volume terms, nearly 14% of U.S. crude oil imports come from the continent, as compared to almost 18% from the Middle East. Within a decade, Africa is projected to be the
source of well over 20% of our imported oil.
The U.S. is now Africa's second-largest industrial supplier. U.S. companies have edged out European and Asian competition to complete major deals in the region. Coca-Cola recently made a $35 million investment in a production and distribution facility in Angola; a consortium comprised of Enron and the Industrial Development Corporation signed a $2 billion agreement to construct a steel plant in Mozambique

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  • Avatar Bob Self Certification CE Mark, home made table lamps?
    Jun 10, 2007 by Bob | Posted in Other - Business & Finance

    I don t want to pay a consultant for every design I make. What is the process :)

    • # Prepare a Declaration of Conformity. The Declaration of Conformity must contain information adequate for tracing the product back to the manufacturer or the authorized representative in the European Union. It may include a list the directives and standards that your product conforms to, product identification, the manufacturer s name, address and signature. # (If of a type required to be) Register your product in EU Many products, for instance, Class I Medical Devices, are required to be registered in the EU and, if proved, get a Certificate of Registration. Without this Certificate of Registration …