Planning to import medical or protective face masks to the European Union? In this guide, we cover product regulations, EN standards, labeling, certification, and lab testing requirements when importing or manufacturing various types of face masks for the EU.

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Far from all medical and protective face masks on the market are designed to comply with EU standards and regulations. It’s therefore essential to request and verify all relevant compliance documents and lab test reports, and product labels, before importing face masks from suppliers in China, or other countries.

Checklist

Note that while the “FFP” standards are maintained by the European Committee for Standardization (CEN), the “N” standards are released by the American National Institute for Occupational Safety and Health (NIOSH).

Here their respective filter capacity:

Also, note that KN95 is a standard maintained by the General Administration of Quality Supervision, Inspection and Quarantine of the PRC, which is considered to provide performance similar to N95.

The Medical Devices Directive (MDD) applies to medical devices to be placed in the EU market, as such, surgical masks, which are mainly designed to protect the patient, fall under the scope of the MDD. The directive sets requirements for face surgical masks such as testing procedure, classification, safety performance and more concerning the face mask products.

Generally speaking, surgical masks are classified as a Class I medical device. However, if your masks are sterile, then they classified as Class I (sterile).

Also, note that according to the 2007 amendment of the Directive, when the mask is designed to protect both the patient and the wearer, it shall comply with the PPE Directive as well.

To ensure the product’s effective safety and performance, your face masks shall be tested in order to prove compliance with the MDD requirements. With that said, third party lab testing is the only way to verify whether your face masks are compliant or not.

EN 14683 Harmonized Standard

The EN 14683: Medical Face Masks is a harmonized standard under the MDD, and provides requirements and test methods for medical face masks.

In general, the EN 14683 standard classifies the masks into three categories based on their performance. Here we list an overview of those three types of masks: