Regulation on Personal Protective Equipment

(EU) 2016/425

The Personal Protective Equipment Regulation (EU) 2016/425 addresses products that protect the health and safety of the user. Among others, products that protect against normal weather events and against moisture and humidity during dishwashing are excluded. They are divided into 3 classes, according to which Class III is the one with the highest requirements. Class I products can be placed on the market under the manufacturer's own responsibility. Class II and III products require the involvement of a Notified Body. 

Important notes on this directive / regulation on personal protective equipment (PPE) compact:

  • Search words PPE Regulation 2020, PPE Regulation PDF? Please contact us for a consultation.
  • Particularly relevant at present is the PPE regulation by Corona / PPE regulation mouth protection (as of February 2021). Because when selling e.g. FFP2 masks, this regulation must be particularly taken into account by distributors. For more information, see our article on the compliant sale of FFP2 masks

These products are affected by the regulation for personal protective equipment

Typical products are

  • Sunglasses
  • Helmets
  • High-visibility vests
  • Work gloves
  • FFP masks

Products for self-defense, for example, are excluded.

Legally compliant implementation of the personal protective equipment regulation

The Personal Protective Equipment Regulation requires, among other things, the preparation of a risk assessment of the product for implementation. In addition, a classification (I - III) of the product must be made. The result of the assessment and classification results in a list of tests that must be performed on the product. The findings from the test reports are part of the technical documentation of the product and the basis of the EU declaration of conformity to be drawn up.
We help you with our customer-oriented services to implement the respective requirements for class I products. For class II - and III - products trade-e-bility GmbH cooperates with the Notified Bodies.

-> Only those who act in compliance with the law are safely protected from official sanctions. We help you to implement the necessary measures.

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