Why is it still not Why is it still not Why is it still not

Why is it still not Why is it still not Why is it still not

Original title: Why is it still not recognized by the European Union after obtaining CE certification? Recently, market supervision departments in Shanghai, Shenzhen and other places have strengthened control and severely cracked down on illegal certification of epidemic prevention supplies. As of last week, more than 120 production enterprises and more than 1400 business enterprises have been inspected, and 5 cases have been filed. It is reported that many of these cases are related to suspected CE certification fraud. Why is there a problem with your CE certification? How to distinguish the true from the false? First, why are they investigated and punished? Take the export of masks as an example, first of all, let's understand why your masks will be investigated and punished, mainly for the following reasons: 1. Incomplete qualifications Export masks should include the following qualifications: 1. Import and export licenses are required for epidemic prevention materials that are not managed by medical devices, such as ordinary masks. 2. Medical masks and other certificate-related epidemic prevention materials can be exported directly if the production enterprises have the right to import and export; Foreign trade companies need to add sales of medical devices within their business scope, and record Class II medical devices. When exporting, they also need to attach relevant qualification certificates and test reports of medical devices from manufacturers. Certification required for some major countries: (only a few major countries are listed here) KF certification in Korea, PDMA certification in Japan, FDA certification in the United States, CE certification in the European Union and TGA registration in Australia. 2. Certificate fraud Taking the export to the European Union as an example, there are frequent cases of enterprises forging CE certificates. Recently, Putuo Market Regulatory Bureau seized a case of CE certificate fraud. On April 14, when the Putuo District Market Supervision Bureau supervised and inspected the business premises of a Shanghai Daily Commodity Co., Ltd.,Quickly Delivery Disposable Protective Clothing, it was found that the "CE" logo was printed on the surface, packaging bags and outer packaging boxes of the "KN95 Protective Mask" mask products produced and packaged by the company. And provide a "CE" certificate to indicate that it has received "CE" certification. After investigation, the "CE" certificate provided by the company is a false certificate. Expand the full text 3. The certificate is true , but not recognized Your certificate is indeed issued by a company, but the company is not recognized by the European Union, then your "true CE certificate" will certainly not pass. In fact, this so-called genuine certificate is not issued by the authorized body of the European Union, so it is also invalid. 2. What kind of CE certificate is formal? The European Union has an authorized body with unified supervision and certification qualifications,3 Ply Disposable Protective Face Mask, and the audit and issuance of CE certification requires these authorized bodies, that is, if you want to get a formal CE certificate, you must find a formal certification body. The European Union grants each institution a unique four-digit code, namely the announcement number, and the application and issuance of CE certificates must be issued by the announcement number authority authorized by the corresponding regulations and directives. At present, there are only more than 2,000 institutions certified by the European Union. We can find the detailed information of these bulletin numbers on the official website of the European Union. 3. How to distinguish the authenticity of CE certificate? 1. Inquiry on the official website of the notified body Most of the EU certification authorities will open the function of inquiring certificates on their own official websites. After logging on to the official website of the authority, there will be a page for inquiring certificates. By entering the manufacturer's English name, certificate number and other information, you can query whether there is a matching CE certificate. If so, it may be a genuine certificate. Of course, because of their own official website, CE Certificate KN95 Mask ,Full Body Disposable Coverall, there is also the possibility of falsehood, so we need to continue to review. 2. European Union official website organization inquiry Check the issuing agency of the certificate on the official website of the European Union to see if it has the corresponding certification qualification of the European Union Medical Device Directive MDD 93/42/EEC or MDR Medical Device Regulation (EU) 2017/745. As mentioned above, if it is not the issuing authority of EU certification, the certificate issued by it will certainly be invalid. ① Please consult the institutions authorized by MDD 93/42/EEC Medical Device Directive on the official website of the European Union. It is worth noting that from May 26, 2020, MDR (EU) 2017/745 Medical Device Regulation will formally replace the current MDD Medical Device Directive of the European Union. Notified bodies with MDR authorization can be found on the EU official website. Please refer to the institutions authorized by MDR (EU) 2017/745 Medical Device Regulation on the official website of the European Union. 3. Process analysis and identification of CE certification Take the mask as an example, first of all, we need to confirm whether the mask is a medical device. Masks are divided into medical masks and protective masks, which must be exported to Europe and the United States in accordance with the relevant EU regulations: Personal protective mask: Regulation is EU2016/425 (PPE); The standard is EN149 Medical mask: Regulation 93/42/EEC (MDD) or EU2017/745 (MDR); The standard is EN14683 ① Personal protective mask Personal protective masks are not medical devices and do not need to meet the requirements of EU medical regulations. They can complete CE certification according to the PPE Personal Protection Directive. At present, there are 112 notified bodies authorized by the PPE Personal Protection Directive on the EU official website. Please refer to the European Union official website (EU) 2016/425 Personal Protective Equipment Authorized Organization. ② Medical mask Medical masks need to be certified according to medical device regulations. Here we need to confirm whether it is sterile or not. Sterile medical mask: It belongs to a class of medical products with sterilization in the European Union, and must be certified by CE in accordance with the Medical Device Directive/Regulation MDD/MDR. In this case, an authorized notified body must be involved. Non-sterile medical mask: the enterprise shall make CE self-declaration according to the MDD/MDR of the medical device directive/regulation. The enterprise does not need to be certified by the notified body. After preparing the corresponding documents and test reports, it can complete the declaration of conformity by itself. IV. Other issues 1. Which EU countries need CE certification? EU countries: Finland, France, Germany, Greece, Austria, Belgium, Denmark, Ireland, Italy, Luxembourg, Netherlands, Portugal, Spain, Sweden, Estonia, Latvia, Lithuania, Poland, Czech Republic, Slovakia, Malta, Cyprus, Bulgaria, Hungary, Slovenia, Romania. Note: The following countries are non-EU but still require the CE marking: Iceland, Liechtenstein, Norway. Semi-EU country: Turkey. 2. How long is the CE certification valid? The validity period of CE certificates applied by enterprises is generally about 5 years, but the validity period of specific certificates depends on the specific situation of EU CE certification regulations. ① The standards and instructions for product implementation are updated, which requires product evaluation and review; ② If the structure of the product itself and the process flow change, it also needs to be handled again; ③ If the validity period of 5 years has passed, it shall be handled again. 3. Process of handling CE certification ① Certification application-the enterprise provides the technical data of the product,Medical Disposable Coverall, and the certification body determines the applicable directives and standards according to the data; ③ Signing the contract-the enterprise and the certification body sign the CE mark certification contract; ④ Product pre-inspection-the certification body sends the samples to the authorized relevant laboratory for testing; ⑤ Final inspection of products-the enterprise adjusts the products, completes the relevant procedures, and the laboratory gives the final test report; ⑥ Enterprise rectification: the enterprise carries out rectification according to the final inspection report; ⑦ Technical review: the laboratory conducts technical review on the products; ⑧ Issuance of certificate-the notified body authorized by the European Union shall issue a certificate to the product if the product passes the evaluation. All kinds of certification information can be concerned about the certificate fruit fruit! Return to Sohu to see more Responsible Editor:. zjyuan-group.com


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