Respiratory protective equipment (RPE) and civil masks

There are three main types of masks covering the nose and mouth:

  • civil masks
  • surgical masks
  • respiratory protective equipment.

Masks have different purposes of use and are covered by different legislation.

Civil masks include reusable cloth masks and disposable masks made of different materials. The purpose of civil masks is to reduce the spreading of droplets. Civil masks are common consumer goods. They cannot have a CE marking.

Surgical masks are products intended to protect others, such as patients, and not their users. They are classified as medical devices. Surgical masks classified as medical devices must have a CE marking. 

Respiratory protective equipment is personal protective equipment. Its purpose is to protect the user of the product. Among others, respiratory protective equipment must have a CE marking and the four-digit identification number of the relevant notified body controlling their quality.

All of the above three product types can be available to consumers. 

This page contains more information on the requirements for civil masks and respiratory protective equipment. For more information on surgical masks, go to Fimea’s website.

We have arranged open Skype info sessions. You can view the the presentation in PDF format or watch the recording (in Finnish).

 

Frequently asked questions

Requirements for respiratory protective equipment

Documentation

Civil masks

Requirements for chemicals

Marketing products