In the EU market, the "CE" mark is a mandatory certification mark, whether it is a product produced by enterprises within the EU, or products produced in other countries, in order to circulate freely in the EU market, must be affixed with the "CE" mark to indicate that The product meets the basic requirements of the European Union's "New Approaches to Technical Harmonization and Standardization" directive. This is a mandatory requirement under EU law.
CE certification is the core of the European Directive constitutes the "main requirements", that is, limited to the product does not jeopardize the safety of human beings, animals and goods in terms of the basic safety requirements, rather than the general quality requirements, coordination of the Directive only provides for the main requirements of the general requirements of the Directive is the task of the standard. Therefore, the precise meaning is: CE mark is a safety mark of conformity rather than quality mark of conformity.
The general procedure for obtaining CE marking of medical devices:
1. The manufacturer's relevant laboratory (hereinafter referred to as the laboratory) to make a preliminary application orally or in writing.
2. The applicant to fill out the CE-marking application form, the application form, product instructions and technical documents sent to the laboratory (if necessary, the applicant company is also required to provide a prototype).
3. The laboratory determines the test standards and test items and quotes.
4. The applicant confirms the offer and sends the sample and relevant technical documents to the laboratory.
5. The applicant provides technical documents.
6. The laboratory sends a fee notice to the applicant, and the applicant pays the certification fee according to the fee notice.
7. The laboratory conducts product testing and reviews the technical documentation.
8. Technical document review includes:
a. Whether the document is complete.
b. Whether the documentation is written in an official European language (English, German or French).
9. If the technical documentation is inadequate or not in the required language, the Laboratory will notify the applicant to improve it.
10. If the test fails, the Laboratory will notify the applicant in a timely manner and allow the applicant to make improvements to the product. In this way, until the test passes. The applicant should change the technical information in the original application to reflect the actual situation after the change.
11. The Laboratory will notify the applicant of the additional charge for the rectification costs covered in sections 9 and 10 of this page.
12. The applicant will be required to pay the rectification costs in accordance with the supplementary fee notice.
13. The Laboratory provides the applicant with the test report or technical file (TCF), and the CE Certificate of Conformity (COC), and the CE marking.
14. The applicant signs a self-declaration of CE assurance and affixes the CE marking to the product.
14.