Originally published as Intelligence | Your CE certificate is real, but invalid! COVID-19 is raging, and many countries around the world have suspended shipping. A large number of masks exported to Europe were detained and rejected by the customs; the money was spent, the masks were issued, and they could not clear the customs in Europe! Source | Mike | CCQS Editor | Fraida CE certification, as a necessary document for the legal sale of Chinese products in the European Union, has recently become the focus of the medical device market. Chinese enterprises and bosses are dazzled by the various CE certificates issued by various certification bodies and intermediary companies. At present, many non-qualified intermediary agencies mislead enterprises to make wrong choices and issue invalid CE certificates by taking advantage of their ignorance of EU regulations, which makes enterprises face huge commercial risks in the process of exporting to the EU. We can't say that the certificate is false. It is true. To make an analogy: You come to China to drive with an American driver's license? Definitely not! We don't recognize TA's certificate. TA's certificate is true in the United States, but it doesn't work well here. What is the classification of protective masks in the EU? The grades of protective masks are divided into FFP1, FFP2 and FFP3, as shown in the figure below, which are typical styles of protective masks. Expand the full text The applicable regulation for protective masks is (EU) 2016/425 Personal Protective Equipment Regulation,Medical Disposable Coverall, which belongs to Class III products. The test standard is EN149: 2001 + A1: 2009. Correct mode for CE certification of protective respirator According to the (EU) 2016/425 PPE regulation, protective masks must obtain the certificate of Module B (type inspection certification) + Module C2 (internal quality control + random product supervision and spot check) or Module D (production process quality control) before they can be legally sold in the EU. To put it simply, you must choose either Module B + Module C2 or Module B + Module D. What kind of certification body can be engaged in CE certification of protective masks? Only Notified Bodies authorized by the European Commission (EU) 2016/425 PPE Regulation for respirator products Module B, Module C2 and/or Module D are authorized to carry out CE certification activities for protective respirators. Any Notified Body not authorized by PPE regulations, Notified Body not qualified by Module B, C2 and/or D,KN95 Face Mask, and intermediary agency not a Notified Body shall not be authorized to conduct CE certification activities for protective masks. At present, the more prominent problem exposed in China is that a large number of non-qualified certification bodies and intermediaries, taking advantage of enterprises'ignorance of EU regulations, mislead enterprises to make wrong choices and issue a large number of invalid CE certificates, which makes enterprises face huge commercial and legal risks in the process of exporting to the EU. There are four steps to confirm whether a certification company is a regular PPE CE certification body and can carry out CE certification activities for protective masks. Step 1: Check the official website of the European Union for the information of the notified body. Website: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notifiedbody.main All Notified Bodies authorized by the European Commission are publicly available on this website. You can check the information and scope of authorization of the Notified Body according to its number. Step 2: Determine if the Notified Body is authorized by PPE Regulation (EU) 2016/425 The scope of authorization of each notified body is different. Without the authorization of PPE Regulation (EU) 2016/425, it is not authorized to carry out CE certification activities for protective masks, and the certificates issued by it are not in conformity with EU law. If the body has the authorisation of the PPE Regulation (EU) 2016/425, the scope of its qualification is shown as follows: Step 3: Determine if the Notified Body has a subclass for respiratory protection There are nine categories of product authorization in PPE regulations, and the scope of authorization of each PPE certification notified body is also different. If there is no sub-category of respiratory protection, CE Certificate KN95 Mask ,Medical Quickly Delivery Antivirus Coverall, even the PPE certification notified body can not engage in CE certification activities for protective masks. Query method: Click the "HTML" or "PDF" link on the right side of the PPE authorization on the official website to check whether there is a subcategory authorization for respiratory protection, as shown in the red box in the following figure: Step 4: Confirm whether the Notified Body can be authorized for Module B, C2 or D A Notified Body is authorized to issue a Module B, C2 and/or D certificate only if it has completed the Module B, C2 and/or D qualification. The authorization is shown in the red box in the following figure: Manufacturers can only enter the EU market legally after obtaining the Module B + Module C2 certificate or the Module B + Module D certificate. If the certification notified body only has the authorization of some Module B, C2 or D, then it has no right to issue certificates without recognized qualifications, and the enterprise holds its certificates and can not legally sell them in the EU market. Which CE certificates circulating in the market do not comply with EU regulations? At present, there are many kinds of CE certificates circulating in the market, and it is difficult for enterprises to judge which are legal and which are not in line with EU law. Here, Furuida Xiaobian collects some CE certificates of protective masks that do not conform to EU regulations for display and analysis, hoping to help you master the method of identification. The following certificates are from the Internet, and the comments are only based on the requirements of relevant EU regulations. ” ECM 1282 Italian Notified Body Italian Notified Body ENTE CERTIFICAZIONE MACCHINE SRL, Publication No.1282 The agency does not have the authorization of PPE Regulation (EU) 2016/425 and therefore does not have the authority to issue a CE certificate for protective masks, which does not comply with EU law! CIC An intermediary company in China An intermediary company in China, which is not an EU Certification Notified Body, has no right to issue a CE certificate for protective masks, which has no legal effect! CELAB 2037 Italian Notified Body Italian Notified Body CELAB SRL, Publication No.2037 The agency does not have the authorization of PPE Regulation (EU) 2016/425 and therefore does not have the authority to issue a CE certificate for protective masks, which does not comply with EU law! AENOR 0099 Spanish Notified Body Spanish Notified Body AENOR INTERNACIONAL, S. A., Publication No.0099 Although the agency has the subcategory of masks authorized by PPE Regulation (EU) 2016/425, it can only conduct Module D audits and has no right to issue Module B type inspection certificates, so its issuance of CE certificates for protective masks does not comply with EU law! ICR 2703 Polish Notified Body Polish Notified Body ICR Polska Sp. Z o. O., Bulletin No.2703 The agency is not authorized by the PPE Regulation (EU) 2016/425, so it is not authorized to issue CE certificates for protective masks, which are not in compliance with EU law! Furuida editor's concluding remarks Crisis contains business opportunities, but certification must be cautious! Be sure to look for formal counseling agencies and well-known notice agencies, not because of temporary "savings", in the end, money is spent, CE is available,Antivirus Disposable Mask with CE Certificate, things are sent, to Europe can not clear customs, you really fell! [Article Source] Furuida returns to Sohu to see more Responsible Editor:. zjyuan-group.com