Medical Equipment and CE approval

1. What is CE approval?

CE Marking is European Product Safety Regulations. Products and installations that are put into use in the European market must comply to the CE marking and CE certification regulations. Only if products comply to the European Directives can they gain the CE approval and be supplied with a CE certificate.

The CE mark certification experts of CE Solutions evaluate medical product documentation and carry out all procedures required so that the CE mark or CE marking results in the required CE approval. Once all the procedures have been correctly implemented by our experts regarding the CE certification the CE mark can be legally brought onto the product.

CE certification experts can indicate the correct procedures related to the CE mark the CE marking and CE certification so a correct CE approval can be achieved. Our CE mark certification experts carry out all electrical and mechanical tests, carry out risk assessments, compile technical files, verify technical documentation and issue the CE declaration of conformity.

2. Where’s CE comes from?

It constitutes the European Directive core "requirements" May 7, 1985, in the EC has a specific meaning as "requirements" to develop and implement a directive purpose, that is only limited to the products do not endanger humans, animals and goodsthe safety aspects of the basic safety requirements, rather than the general quality requirements, coordination of instruction only requires that the main requirement, general instructions to the standard task. The product complies with the relevant instructions about major requirements, will be able to attach a CE mark, rather than ruled that the provisions of the general quality of the ability to use the CE mark in accordance with the relevant standards. Therefore, the exact meaning: CE mark is a safety inspection mark rather than quality mark. In the 1940s, Western European countries feel that, in the United States and the Soviet Union between the two powers to ensure their own safety, improve its international status, speed up economic development, must unite, thus pushing the process of European integration. European integration can be divided into five levels: the establishment of a free trade zone, customs union, unified market, economic and monetary union and political union.  

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