PPE

The term PPE refers to Personal Protective Equipment used in occupational safety. This is anchored in the PPE Regulation (EU) 2016/425, which sets out requirements for the design and manufacture of personal protective equipment. It also regulates the free movement of PPE within the Union.

Scope of application:

Personal protective equipment includes special protective clothing and devices used for self-protection by users in health-threatening activities.

They are used throughout the commercial sector, in healthcare, and by sovereign organisations (e.g., police, fire brigade, or military organisations).

Specifically harmonised standards published by the European Commission set specific requirements for the respective products.

Categories:

The PPE Regulation divides Personal Protective Equipment into three risk categories that reflect the degree of hazard.

Category I: Minimal risks (e.g., safety glasses or protective gloves)
Category II: Intermediate risks (e.g., helmets or protective clothing against cuts)
Category III: High risks (PPE that protects against life-threatening dangers, such as respiratory protection devices)

The higher the category, the more complex the conformity assessment procedures the manufacturer must carry out.

For Category II products, an EU type examination by a notified body is required. For PPE in Category III, due to the higher risk, both the EU type examination and surveillance by a notified body must be carried out.

Only if an EU type examination certificate is available, the manufacturer is authorised and obliged to affix the CE marking on their product. For PPE in Category III, the CE marking is also supplemented by the registration number of the notified body monitoring the manufacturer's ongoing production.