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Reanny Medical Devices Management Consulting Co., Ltd.

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EU CE certification

In the EU market, the "CE" mark is a mandatory certification mark. Whether it is a product produced by internal enterprises in the EU or products produced in other countries, in order to circulate freely in the EU market, it is necessary to attach the "CE" mark to indicate that the product meets the basic requirements of the EU's "New Methods for Technical Coordination and Standardization" directive. This is a mandatory requirement of EU law for products.

EU CE certification refers to basic safety requirements that are limited to products that do not pose a threat to human, animal, and goods safety, rather than general quality requirements. Coordinated directives only specify primary requirements, while general directive requirements are standard tasks. Therefore, the accurate meaning is that the EU CE certification CE mark is a safety conformity mark rather than a quality conformity mark. It is the "main requirement" that constitutes the core of the European Directive.

The "CE" mark is a safety certification mark that is considered a passport for manufacturers to open and enter the European market. CE stands for Unification of Europe.

More than 1200 certification bodies have obtained EU CE certification, the vast majority of which are located within the borders of EU member states. Normally, an NB is only authorized by the European Union to carry out certification in one or several modes for a certain category or categories of products. In other words, an EU authorized certification body may not be able to certify all product categories, and even for the authorized product categories, it is usually not authorized for all models. For each EU product directive, there is usually an authorized certification body NB directory for that product directive.

(1) The Declaration of Conformity/Declaration of Compliance independently issued by the enterprise is a self declaration document and should not be issued by third-party organizations (intermediaries or testing and certification bodies). Therefore, the EU format enterprise Declaration of Conformity can be used as a substitute.
(2) Certificate of Compliance is a declaration of conformity issued by a third-party organization (intermediary or testing certification body), which must be accompanied by technical information such as test reports and TCF. At the same time, the enterprise must also sign a Declaration of Conformity.
(3) EC Attestation of Conformity is a certificate issued by the notified body (NB) of the European Union. According to EU regulations, only NB is eligible to issue EC Type CE declarations.

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