Masks bearing the CE marking are commonly referred to as CE-certified masks. The presence of the CE marking on a mask indicates that the mask may circulate and be sold within the European Economic Area (EEA). In addition to the CE marking, surgical masks must meet the requirements of EN 14683 in order to circulate and be sold in the EEA. EN 14683 can be described as the standard covering requirements and test methods for medical face masks. Under the Medical Devices Regulation, surgical intervention masks are evaluated as Class I devices. Surgical masks are suitable for use by healthcare personnel.
Manufacturers must affix the CE marking to the masks they produce. Masks bearing the CE marking are considered to have been placed on the market in accordance with the relevant regulations and standards. Products without a CE marking are products that do not meet legal requirements and whose sale is not permitted. The manufacturer itself must affix the CE marking to its products. Masks bearing the CE marking demonstrate conformity with European norms. Depending on their intended use and type, respiratory masks should be manufactured in accordance with standards such as EN 136, EN 140, EN 143, EN 149, EN 14378, EN 12941, EN 12942, EN 1835 and EN 14683. In addition to the basic standards of the European Union, masks may also be manufactured according to another international standard specified by other countries, such as the N95 standard.
According to the relevant EN 14683 standard, the following tests are performed depending on the selected mask type:
- Bacterial Filtration
- Differential Pressure
- Synthetic Blood Penetration Test
- Microbiological Cleanliness
Masks, which are one of the measures used to help prevent viral diseases, must be manufactured in accordance with CE-related standards and placed on the market according to the applicable requirements.
Mask classifications for which CE certification may be obtained are as follows:
- Surgical Mask CE Certificate
- Personal Protective Mask CE Certificate
- Medical Mask CE Certificate
- Medical Face Mask CE Certificate
- Face Mask CE Certificate
- Textile Face Mask CE Certificate
Is It Legal to Sell Masks Without CE Certification?
If mask manufacturers do not carry out the required CE certification or declaration procedures, they cannot place their products on the market in Europe or Türkiye. In addition, if such deficiencies are identified during inspections by the relevant authorities, they may be subject to penalties. Therefore, manufacturers and assembly companies must obtain the required CE certificates or issue the applicable self-declarations in order to affix the CE marking to their products.
Professional services are provided to mask manufacturers for laboratory testing, technical-file audits and CE certification procedures within the scope of the relevant standards under Regulation (EU) 2016/425 on Personal Protective Equipment and Directive 93/42/EEC on Medical Devices (MDR-2017/745/EC Medical Device Regulation). Please contact us to benefit from these services and obtain detailed information.
