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CE marking Personal Protective Equipment (PPE 2016/425)

The Personal Protective Equipment Regulation 2016/425/EU (PPE)

Personal protective equipment (ppe’s) is defined as any device or appliance designed to be worn or held by an individual for protection against one or more health and safety hazards.

Besides this, the following items are also considered as personal protective equipment:

  • a unit composed of several items or items connected by the manufacturer to protect the individual against one or more potentially simultaneously risks;
  • a protective device that is combined with non-protective equipment worn or held by the individual for the execution of a specific activity;
  • interchangable PPE components which are essential to its satisfactory functioning and used exclusively for such equipment.

Annex II of the Personal Protective Equipment Directive contains the basic health and safety requirements which a protective equipment must meet. Depending on the application the protective equipment can protect the individual against noise, vibrations, contamination and electricity.

Personal protective equipment must comply with essential safety requirements and must bear the CE marking. The aplicable requirements vary depending on the classification of the personal protective equipment. The PPE is divided into the following groups:

  • Simple design (example, garden gloves)
  • Neither simple, nor complex
  • Complex design (example, breathing apparatus)

CE marking personal protective equipmentThe classification of the personal protective equipment is determined in accordance to the Personal Protective Equipment Regulation and related Guideline. Based on the classification of the personal protective equipment the conformity procedure is defined.  

By affixing the CE marking on protective equipment the manufacturer or importer ensures that the product comply with the basic health and safety requirements of the Personal Protective Equipment Regulation 2016/425/EU. The personal protective equipment bearing CE marking can be traded freely withing the European Economic Area (EEA).

Products that fall outside the scope of the Personal Protective Equipment Directive:

  • protective equipment designed for armed forces and law maintanance;
  • protective equipment for self-defense;
  • protective equipment designed for particular use as protection agains weather conditions: moisture, water and heat;
  • protective equipment designed for the rescue of persons on vessels or aircraft;
  • helmts and visors for users of two or three-wheel motor vehicles.

How can Certification Company help you?

Certification Company performs complete CE marking for personal protective equipment in accordance with Personal Protective Equipment Directive 89/686/EEC and Personal Protective Equipment Regulation 2016/425 that will come into force on the 21st of April 2018.

In addition to complete CE certification of personal protective equopment you can also contact us for the following services:

  • Classification research to determine relevant requirements;
  • Risk analysis in accordance with the PPE Regulation 2016/425/EU;
  • Product Conformity tests based on European (harmonized) standards;
  • Complete guidance with Notified Body, when applicable;
  • Compiling and verifying the Technical Files;
  • Drafting and checking the User Instructions and Labels;
  • Verifying and compiling an EU Declaration of Conformity;
  • Guidelines on affixing the CE marking correctly;

Six steps for CE marking personal personal equipment

The Personal Protective Equipment Regulation contains legal obligations that must be met. The following step-by-step plan has been drawn up for the manufacturer.

  1. Product classification: Determining whether the product falls into the scope of PPE Regulation and classification of personal protective equipment on the basis of established criteria.
  2. Economic operator classification: Defining the role of economic operator withing the Personal Protective Equipment Regulation.
  3. Conformity procedure: can be divided into the following parts:
    • Carry out the product tests based on European (harmonized) standards;
    • Draw up the procedures to ensure the conformity of series production;
    • Provide identification element of the product and the economic operator;
    • Provide instructions and safety information;
    • Develop procedures for taking corrective measures.
  1. Technical Files: Drawing up the Technical Files (including User Manual) based on which the product conformity can be assessed.
  2. EU Declaration of Conformity: Drafting the EU Declaration of Conformity and declaring that the product complies with the Personal Protective Equipment Regulation.
  3. CE marking: As soon as the product complies with the Personal Protective Equipment Regulation and the related standards, the CE marking will be affixed.

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CE marking personal protective equipment

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The cost of CE Certification for personal protective equipment varies by type of product. Request a quote to understand what your certification will cost.


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