Personal Protective Equipment.
Personal protective equipment, also known as PPE or PPE (Personal Protective Equipment), is designed and manufactured to be worn or held by a person to protect against one or more risks to that person's health or safety.
Personal protective equipment sold on the European market must comply with Regulation 2016/425. This sets requirements for the design and manufacture of personal protective equipment sold on the European market.
Risk categories.
Personal protective equipment is classified into three risk categories.
Category I
Products that protect the user from minimal risks and superficial injuries, such as abrasions, contact with fairly harmless cleaning agents and prolonged contact with water, eye exposure to UV sunlight and weather conditions that are not extreme in nature. Examples include sunglasses, ski goggles and garden gloves.
Category II
Medium-risk products that do not fall into categories I and III. Examples include swim bracelets, oven mitts, safety glasses, dust masks and hearing protectors.
Category III
Products that protect against high risks with very serious consequences, such as contact with hazardous substances and mixtures, radiation, extreme cold and heat, electric shock, deep cuts, gunshot wounds, falls from great heights, drowning and harmful noise. Examples include safety shoes with a safety nose or sole and antistatic effect and harnesses.

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Our consultants have extensive experience in training, advising and supporting companies. They chart your compliance with the obligations of Regulation 2016/425. Together with you, we will find the optimal solution for your organization.
Conformiteitsbeoordelingsprocedure
Regulation 2016/425 imposes obligations on companies selling personal protective equipment on the European market. These obligations include conducting a conformity assessment procedure and affixing a CE marking. Without a CE mark, personal protective equipment is not allowed to be placed on the European market.
The conformity assessment procedures to be followed are defined by risk category and subdivided into modules A, B, C, C2 and D. These modules cover the performance or commissioning of internal production control, EU type examination, supervised product controls and quality assurance of the production process.
Your obligations in a row.
Is your product designed and manufactured to be worn or held by a person to protect against one or more risks to that person's health or safety? Then your product is a personal protective equipment.
Consider the general, physical, thermal, chemical and mechanical hazards applicable to your product. Consider not only the intended use, but also the reasonably foreseeable use of the personal protective equipment.
Determine whether your product must protect the user from minimal, medium or high risks. The risk category determines what further obligations you have regarding the conformity assessment procedure to follow.
Assess which safety requirements from Annex II of Regulation 2016/425 apply to your product. Personal protective equipment must provide adequate protection against the risks for which it is intended. Then design and manufacture your product taking into account this assessment.
Without complete technical documentation, you may not sell your product on the European market. Make sure the technical documentation for your product is complete. Required parts of your technical documentation are:
- A description article and its intended use,
- a risk assessment,
- A list of applicable health and safety requirements,
- technical specifications, such as a bill of materials and design drawings,
- references to applicable harmonized standards,
- reports in which the product is tested according to these standards,
- A description of the assurance of conformity during production.
Prepare instructions for use and provide the product and its packaging with the necessary information according to the general requirements in Annex II of the regulation. Add these instructions and markings to your technical documentation.
Draw up an EU declaration of conformity according to Annex IX of Regulation 2016/425. This EU declaration of conformity must be attached to your technical documentation. You are also required to attach the EU declaration of conformity to the product or make it available on your website.
If the personal protective equipment meets all essential safety requirements, you may affix the CE mark to your product. The CE mark must be visible, legible and indelible.
Does your personal protective equipment fall under risk category II or III? Then you must have an EU type examination performed by an accredited body (Notified Body). During this examination, the technical documentation and a sample of the product are assessed. In case of conformity, you will receive a Certificate of EU Type Examination (CE Certificate).
If you want to sell personal protective equipment in risk category III, you have additional obligations regarding having recurring product inspections and a quality system assessment by an accredited body.

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