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The EU classifies masks into two categories by use: personal protective masks and medical masks.
1. Personal protective masks
Personal protective masks are not medical devices but must comply with the EU Personal Protective Equipment Regulation EU 2016/425 (PPE), with CE certification issued by a notified body and the corresponding standard EN149. Application flow: EN149 test report → apply for Module B certificate → apply for Module C2 → CE certificate issued.
2. Medical masks
Medical masks are CE marked under Directive 93/42/EEC (MDD) or the EU Medical Device Regulation EU 2017/745 (MDR), with the corresponding standard EN14683. Sterile medical masks must be CE certified by a notified body. For non-sterile medical masks, enterprises may issue a CE self-declaration of conformity. Application flow: EN14683 test report → DOC self-declaration of conformity → TCF documentation → EU authorised representative registration.
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