PPEförordning

The PPE Regulation, officially Regulation (EU) 2016/425, is a European Union legal framework that governs the placing on the market of personal protective equipment (PPE). It aims to ensure that PPE sold within the EU provides adequate protection to users against risks and that it is placed on the market under fair competition. The regulation replaced the previous PPE Directive (89/686/EEC).

This regulation defines what constitutes PPE and sets out the essential health and safety requirements that PPE must meet to be legally sold in the EU. It also establishes the conformity assessment procedures that manufacturers must follow to demonstrate compliance. These procedures can involve a Notified Body, which is an independent organization designated by an EU country to assess whether a product meets the relevant EU requirements.

Key aspects of the PPE Regulation include manufacturer obligations, importer obligations, distributor obligations, and requirements for Notified Bodies. Manufacturers are responsible for ensuring their products meet the essential health and safety requirements, drawing up the technical documentation, performing the conformity assessment, affixing the CE marking, and issuing an EU declaration of conformity. Importers and distributors also have responsibilities to ensure that the PPE they place on the market complies with the regulation.

The CE marking is a mandatory conformity mark for products placed on the market in the European Economic Area. Affixing the CE marking to a product signifies that the manufacturer has declared that the product meets all the applicable EU requirements, including those of the PPE Regulation. The regulation also covers the free movement of PPE that complies with its provisions throughout the EU internal market.