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If you want to know more about regulatory issues of Medical
Devices, click here.
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How to Get CE Mark |
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The European Community has formally adopted several Directives that apply to Medical Devices. This means that any company, interested in selling a product in one of the European Community countries, must comply with the requirements of the applicable Directive and must mark its product with the CE symbol according to those requirements.
The meaning of the CE MARK symbol is that the product has been carefully reviewed by the regulatory authorities, and has been found to be safe to use and to meet the relevant quality requirements based on the standards that were adopted by the European market (EN, IEC, ISO). Once granted with a CE MARK, you may sell the product without any other limits in every country of the European Community.
The requirements of the CE can be divided into two major categories:
- Quality system Requirements, with which the manufacturer should comply, regarding the development and the manufacturing of the product.
- Safety and reliability requirements the product should meet, which includes items such as biocompatibility, software validation, electrical safety, electromagnetic compatibility (EMC), performance evidence, technical performance evidence, and pre-clinical and clinical evidence.
What are you manufacturing?
Medical Devices or In Vitro Diagnostic Devices?
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