Source: cypress blue device
1. The two CE certificates are invalid
According to the official weibo account of the Shanghai municipal supervision bureau on April 14, the Shanghai municipal supervision bureau has found that some individuals and organizations have released information such as "quick CE certification" through Internet platforms and SMS for the purpose of making profits.
These individuals and organizations induce enterprises to entrust their agents with the so-called "CE certification certificate" which is actually invalid or unnecessary, and charge high fees, which not only cause economic losses to enterprises, but also seriously disrupt the certification market order.
For surgical masks and personal protective masks, the following two documents are not CE certificates.
The first category for surgical masks (non sterile) (the Disposable medical protective mask (not sterile), relevant documents marked on the "CE documents audit (CE Documentation Review)", this type of file is not certification.
The second category is for the Disposable daily productive mask, which is marked with the words "Certificate of Compliance" or similar on the relevant certification documents, but is issued by an authority that is not an eu notified body or, although it is an notified body, the scope of authorization does not cover PPE regulations.
The Shanghai regulatory bureau also said that a large number of certificates issued to domestic mask manufacturers in the name of ENTE CERTIFICAZIONE MACCHINE SRL for mask products (personal protective masks and medical masks (non-sterile)) have appeared on the market recently.
The company's "ECM" logo and CE logo are marked on the documents.It has been determined that ENTE CERTIFICAZIONE MACCHINE SRL is not an authorized certification body in the (EU) 2016/425 (PPE) field and is unable to CE certify personal protective masks.
2.Classification of masks
Recently, the national municipal supervision bureau issued the "face mask and other anti-epidemic products exported to the European Union and the United States market certification information guide", said that the face mask export to the European Union to provide information guide.
According to the guidelines, the eu divides masks into two categories according to their purpose: surgical masks and personal protective masks.
Surgical masks: surgical masks shall be affixed with the CE mark in accordance with eu medical device directive 93/42 / EEC (MDD) or eu medical device regulation eu2017/745 (MDR), and the corresponding standard is EN14683.According to the aseptic or non-aseptic status of mask products, the conformity assessment mode is also different.
(1) sterile surgical mask: CE certification must be conducted by an authorized public body.
(2) non-sterile surgical mask: the enterprise only needs to make the self-conformity declaration of CE and does not need to pass the certification of the announcement body.After the relevant documents and test reports are prepared, the declaration of compliance can be completed by yourself.
Personal protective mask: personal protective mask is not a medical device, but it must meet the requirements of the eu personal protective equipment regulation eu2016/425 (PPE). The authorized public body shall conduct CE certification and issue the certificate. The corresponding standard is EN149.