What is the EU classification for protective masks?
There are three levels of protective masks. They are FFP1, FFP2, and FFP3 (as shown in the figure below). All three are typical styles of protective masks.
The applicable regulations for protective masks are (EU) 2016/425 Personal Protective Equipment Regulations, which are Class III products.
The test standard is EN149: 2001 + A1: 2009.
What are the CE certification modes for protective masks?
According to (EU) 2016/425 PPE regulations, protective masks must obtain Module B (type inspection certification) + Module C2 (internal quality control + random inspection of product random inspection) or Module D (quality control of production process) certificate, for legal sale in the EU.
In simple terms, one must choose Module B + Module C2 or Module B + Module D.
What kind of certification body can engage in CE certification of protective masks?
Only certification notified bodies authorized by the European Commission (EU) 2016/425 PPE regulatory mask products Module B, Module C2 and/or Module D are authorized to engage in CE certification activities of protective masks.
Any certification announcement agency without PPE regulations, certification announcement agencies without Module B, C2, and/or D qualifications, and intermediary agencies that are not certification announcement agencies, have no authority to conduct CE certification activities for protective masks.
Step 1: Check the official website of the European Union for information about the notified body
All certification notified bodies with the authorization of the European Commission are publicized on this website.
Click "Regulation (EU) 2016/425 Personal Protective Equipment", you will find the list of all notified bodies with the authorization.
There are nine categories of product authorizations under the PPE regulations, and the scope of authorization of each PPE certification announcement body is also different. Without the small category of respiratory protection, even the PPE certification notified body cannot engage in CE certification activities of protective masks.
For the 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 small category of respiratory protection authorization, as shown in the red box in the figure below:
The certification notified body is only entitled to issue Module B, C2 and / or D certificates if it has complete qualifications. The authorization display is shown in the red box in the figure above.
Manufacturers can only enter the EU market legally after obtaining a Module B + Module C2 certificate or a Module B + Module D certificate.
If the certification notified the body only has the authorization of some Module B, C2 or D, then it has no right to issue certificates without accreditation, and the company holds its certificate and cannot legally sell in the EU market.