What is CE certification?

CE is the French abbreviation of European Conformity (Conformite Europeene). The "CE" mark (CEmarking) is a safety conformity mark rather than a quality conformity mark, and is the "main requirement" that constitutes the core of the European Directive. For products listed in the CE certification category, they must obtain the CE certification before they can enter the EU market and affix the "CE" mark to indicate that the product meets the basic requirements of the EU "Technical Coordination and Standardization New Method" directive. This is the EU law A mandatory requirement put forward by the product.

At present, 25 categories of products require CE certification, involving home appliances, communication products, and medical equipment.

The European Safety Federation (European Safety Federation) issued the following official warning (warn)!

Regarding the “certificates” used as the basis for the CE marking of PPE (including FFP2/FFP3 masks and goggles), these “certifications” are forged or issued without authorization. These “certificates” have no legal value and cannot be used as the conclusion of the conformity assessment !

As of April 16, the announcement listed 28 non-compliant certification organizations and institutions, of which as many as 17 are not. The compliance agencies are based in China!

How to identify valid information?

1. Certification agency. Used to inquire whether this institution has the authority to issue a CE. Inquire whether the organization is a Notified body, and whether its scope of authorization (legislations), product scope (products) and procedures (procedures) include your products.

Please be sure to find out the authorization requirements of your products under EU standards, and do not ignore the scope of products and procedures.

2. Holder. The title keyword "Certificateholder" or "Manufacturer" is used to check whether the holder and the manufacturer of the product are the same.

3. Certificate number. Look for "No.", "Number" + number. It is used to verify the existence of the certificate on the official website of the notified body.

4. Product name. The title keyword "Product" or "Scope". Here we need to see clearly what kind of product the certificate certifies.

5. According to laws and regulations. (EU) 201 6/425 Personal Protective Equipment Regulation (PPE) 93/42/EEC Medical Device Directive (MDD Directive will be replaced by the new version (EU) 2017/745, which is the Medical Device MDR).

6. Implementation standards. The EU standard for personal protective masks is EN149, and the standard for medical masks is EN14683.

7. Additional conditions. Generally on the last page of the certificate, the keywords "conditions" and "attach".

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CE certificate identification and determination

There are many common false CE certificates, or CE certificates with no legal effect. The editor lists three such CE certificates to help you identify and determine:

1. The first type of false or invalid CE certificate is "Certificate of Compliance" (Certificate of Compliance), referred to as COC certificate.

Companies need to conduct tests to verify the safety and effectiveness of the products. The results and reports of the tests need to be included in the technical documents, and certificates are not required under normal conditions.

In addition, the DOC: Declara-tion of Conformity (DOC: Declara-tion of Conformity) is a regulatory document that needs to be signed by the company to declare compliance with the corresponding regulatory requirements and assume legal responsibility. According to EU regulations, self-declared products do not require any certificate from a third party, but only need to provide a declaration of conformity signed by the company.

This type of fake or non-legally valid certificate of conformity usually has a large CE letter, but does not have the number of the notified body. The subject of the certificate is mostly Certificate of Compliance or Certificate of Conformity, rather than the certificate type of the regulations and corresponding appendices. The content does not include the complete content. The content described in the previous model certificate and the qualification of the certification body cannot be verified on the EU website.

2. The second type of CE certificate with no legal effect is "ECAttestation of conformity" (EU standard compliance certificate).

It is mainly aimed at a class of products and is issued by announcement agencies or third-party agencies to meet the needs of some enterprises. Because in accordance with regulatory requirements, self-declared products are the company's own responsibility.

3. The third type of "CE certificate or report" without legal effect is the technical document review certificate or review report.

This is similar to the second situation, and it is also for self-declared products. Due to the requirements of the competent authority, the At-testation of conformity certificate cannot be issued. Some organizations have changed to the review certificate or review report of technical documents. This kind of certificate and report It is also not recognized by the competent authorities of the European Union.

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CE certification process

The basic process of PPE regulation CE certification:

The KN95 respirator produced by domestic manufacturers in accordance with GB2626-2006 is a respiratory protective equipment in the PPE personal protective equipment in the European Union, and it is a Class II protective equipment. The product must be fully certified by the CE certification notice agency authorized by the PPE regulations for respiratory protection subcategories to complete the Module B+-Module C2 or Module B+Module D certification before it can be affixed with the CE mark and sold legally in the European Union.

1. Provide application form, product pictures and instructions; 2. Prepare product type test report. "(Tested in accordance with EN 149);

3. Review of technical documents (reviewed by the issuing agency);

4. Factory quality system review (the factory system documents are reviewed by the issuing agency);

5. Announcement agency issues CE certificate

Therefore, PPE masks can only be sold on the market with at least two CE certificates of PPE, namely: 1) Appendix V type inspection certificate, 2) Appendix VII (Module C2) certificate, or Appendix VII (ModuleD) certificate.