European medical devices standards

European medical devices standards

Before you can sell a medical device or IVD in Europe, place a CE Mark (CE Marking) on your product. The CE Mark is a quality brand and is not intended for consumers. It is a declaration by the manufacturer which legally binds your product has met all the requirements of the Medical Device Directive (MDD 93/42/EEC), the Directive on In Vitro Diagnostic Devices (IVD 98/79/EC) or Directive of Active Implantable Medical Devices (AIMD 90/385/EEC), as [...]


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European Medical Devices Directive

European Medical Devices Directive

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 [...]

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Medical devices European Directives

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 [...]

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Medical devices European standards

Medical devices European standards

China-Europe: Information on standards and market requirements The Platform of information on Chinese and European standard (CESIP) provides companies with Chinese and European bilingual valuable information on any aspect, from technical standards to the requirements of market access. Launched in the month of October, the CESIP provides detailed information on thousands of standards and is a tool to increase progressively collaboration and foster [...]

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