The European market classifies masks into two main categories: personal protective masks and medical masks. Personal protective masks are primarily used for industrial protection, while medical masks are mainly used in hospitals.

1. Medical Masks:

The corresponding European standard for medical masks is EN14683. This standard classifies masks into three categories based on Bacterial Filtration Efficiency (BFE), breathing resistance, and splash resistance. According to the Medical Device Regulation (MDR) 2017/745/EU, mask products can be managed as Class I medical devices. Depending on whether the product is provided in sterile or non-sterile condition, the certification process differs.

Currently, if a manufacturer has not previously obtained a CE certificate from a Notified Body, it's unlikely to apply for one now. Therefore, masks exported to Europe are only available in non-sterile condition. However, non-sterile does not mean no control over the production environment; EN14683 requires initial bioburden to be no more than 30 cfu/g.

Medical masks can be sterile or non-sterile. According to MDD or MDR requirements, non-sterile masks can be self-declared by the manufacturer, registered with the competent authority of an EU member state, and then marketed. However, sterile masks require Notified Body involvement for review and CE certificate issuance before a Declaration of Conformity can be signed and the CE mark can be applied for market entry. Regardless of Notified Body involvement, manufacturers must comply with regulatory requirements, conduct testing according to recognized harmonized standards or standards meeting EU quality levels, demonstrate product safety and effectiveness, establish technical documentation and a quality management system, and ensure product quality safety and continuous effectiveness.

Technical documentation typically includes seven sections:

1. Device description and specification, including name, intended use, classification, materials, composition, technical specifications, etc.

2. Product labeling and/or instructions for use

3. Information related to product design and manufacturing

4. Compliance with General Safety and Performance Requirements (GSPR) in Annex I

5. Benefit and risk analysis, and risk management documentation

6. Product verification and validation, including preclinical testing and clinical (evaluation) data

7. Post-market surveillance plan

2. Protective Masks:

The European standard for protective masks is EN149, which classifies masks into three categories: FFP1 (minimum filtration efficiency 80%), FFP2 (minimum filtration efficiency 94%), and FFP3 (minimum filtration efficiency 97%). Protective masks must comply with the EU Personal Protective Equipment (PPE) Directive. Protective masks are considered complex design products and require certification by an authorized Notified Body for export to Europe.

PPE Directive product certification scope: KN95, KN90, KN100, KP90, KP95, KP100, FFP1, FFP2, FFP3.

Protective mask certification types:

1) Module B + Module C2 (sample testing, valid for 1 year)

2) Module B + Module D (factory audit, valid for 3 years)

Module B: Technical file review and registration, referring to type examination certification.

Module C2: Sample testing, valid for 1 year. Refers to internal production control and annual random product sampling to ensure product consistency.

Module D: Factory audit, valid for 3 years. Refers to production process quality control to ensure product consistency.

Protective mask CE certification timeline:

1) Module B + Module C2: 6-8 weeks

2) Module B + Module D: 8-12 weeks

3. Benefits of CE Certification

With CE certification, your products gain a special "passport" allowing free circulation across 30 European countries. Following EU expansion, Chinese companies face a larger, uniformly regulated European market. With CE certification, once a product enters one EU member state, it can access all other member states' markets.