IVD CE certification

1, only apply for the IVD is eligible to apply for CE, IVD is the CE directive, then that is to say that if my product has CE certification, then naturally belongs to the IVD products, can be so understood? --CE is the European Union certification of conformity, the owner of the product if the medical device in line with the requirements of the IVD, need to be based on the IVD directive to carry out certification.

2, IVD is a certificate or something else statement? Whether there is an internationally harmonized format - normally, the certificate will reflect the IVD directive.

3, CE certificate if only the manufacturer's self-declaration, and not the announcement of the organization certified, then in the sale of equipment when the two have the same effect? --Some products require a notified body to perform the certification.

4, since the CE certificate is divided into the announcement of the organization certified and manufacturers of self-declaration of two kinds, the former is good to understand, there is the IVD can apply for CE, then the latter who will judge whether it belongs to the in vitro diagnostic products? --Based on the IVD directive in the rules and relevant standards.

5, China's announcement of the certification body can be manufacturers in foreign countries but the products sold in China for CE certification? --Qualified organizations can.

6, CE since the European Union product certification, why Chinese customers will need such a certificate to trade? Is there such a statement or labeling similar to in vitro diagnostic certification in China? If so, under the same circumstances and CE labeling compared to the two, who is more effective or higher level? -- Actually, China's mandatory certification is CCC, and the EU's certification requirement is CE

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