Model of CE certification for protective masks




          With the rapid spread of the new crown pneumonia epidemic, Italy, France, Germany and other countries have fallen, and Europe has become the hardest hit area. In the process of preventing and controlling the epidemic, due to the severe shortage of medical masks, protective clothing and other medical supplies, Europe has released a huge demand for protective equipment. At present, China has achieved a staged victory in the prevention of the new crown epidemic. As the world's largest producer of medical protective equipment, whether it is a traditional medical manufacturer or a new enterprise that has decided to enter this unfamiliar field, it has decided to use excess capacity To sell such products to the European market.
         CE certification is essential for export to the EU market. At present, there are various medical CE certificates on the market, which is dazzling. In WeChat groups of various industries, you can often see someone issuing a so-called CE certificate. Please help distinguish the authenticity. In order to better help everyone, let's talk about the specific identification methods below.
         The mode of CE certification for protective masks is based on (EU) 2016/425 PPE regulations. Protective masks must obtain Module B (type inspection certification) + Module C2 (internal quality control + product random inspection) or Module D (production) Only after the certificate of process quality control can it 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 engage in CE certification of protective masks? Only the certification notice bodies authorized by the European Commission (EU) 2016/425 PPE mask products Module B, Module C2 and/or Module D have the right to engage in CE certification activities for protective masks.
Any certification announcement agency that is not authorized by the PPE regulations, certification announcement agency that does not have Module B, C2, and/or D qualification, or an intermediary agency that is not a certification announcement agency, has no right to conduct CE certification activities for protective masks. At present, the most prominent problem exposed in China is a large number of unqualified certification agencies and intermediaries, which use the enterprises’ ignorance of EU regulations to mislead the enterprises to make the wrong choice and issue a large number of invalid CE certificates, making the enterprises in the process of exporting to the EU. China faces huge commercial risks and legal risks.