JimmieSears JimmieSears's blog : Intelligence | Your CE certificate is real, but invalid! _ Certification
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,Antivirus
Disposable Mask with CE Certificate, 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,Quickly
Delivery Disposable Protective Clothing, 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 ,KN95
Face Mask with Five Layers, 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,Virus
Prevention Mask 3 Ply with Earloop, 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
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