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Personal Protective Equipment Regulation 2016/425

Personal protective equipment (PBMs)are defined bythe Regulation as products intended to be worn or held by a person as protection against one or more hazards that may pose a threat to his health or safety.

The PBM Regulation does not apply to:

  • protective equipment designed for armed forces or law enforcement;
  • protective equipment for self-defence against attackers;
  • protective equipment designed for private use against weather conditions that are not of an extreme nature;
  • protective equipment for exclusive use on seagoing vessels or aircraft;
  • helmets and visors for users of two- or three-wheel motorcycles.

PPE must comply with essential safety requirements and must bear the CE mark in accordance with the Personal Protective Equipment Regulation. The applicable requirements vary depending on the risks against which PPE is intended to protect the user, and are divided into three categories:

  • Category I (includes only minimal risks);
  • Category II ( all other risks than stated in categories I and III) ;
  • Category III (includes only the risks that may cause very serious consequences such as death or irreversible health damage).

PPE Regulation 2016/425

The PPE are classified into three risk categories. These categories decide which essential safety requirements are applicable to a PPE.

CE Marking Personal Protective Equipment – Our Expertise

Certification Company has the necessary skills and expertise at its disposal, in order to fully manage the entire CE certification procedure of your PPE on your behalf. Our specialists are well-informed in regard to the PPE Regulation 2016/425 requirements and will assist you with the compilation of the Technical Documentation. For the purpose of performing product tests we collaborate only with accredited test laboratories. In case your PPE falls into Category II or III which requires an EU-type examination, we will assign a Notified Body on your behalf. You can rest assured that your PPE will be assessed professionally and impartially in order to place it or put it into use legally approved on the market.

CE conformity assessment

Implementation of full CE conformity assessment procedures

Product qualification and classification

Qualification and classification of your PPE product(s)

Risk analysis

Perform the risk analysis

Product testing

Perform (or outsource) product tests in accordance with European (harmonised) standards

EU-type examination

Designate a Notified Body and provide consultancy services in regard to the implementation of EU-type examination

Technical Files

Compilation and assessment of the Technical Documentation

User manuals

Verify instruction manuals, markings and label (safety information)

EU Declaration of Conformity

Draw up the EU Declaration of Conformity and provide instructions for affixing the CE marking

Six steps to CE certification of Personal Protective Equipment

01Product classification

Determine whether the product falls within the scope of the PPE Regulation and/or other CE regulations.

02Risk assessmen

An analysis in order to identify the risks and essential health
and safety requirements that fall within the scope of the PPE Regulation.

03Conformity procedure

Assessment of requirements established in step 2 in accordance with Harmonised European standards.

04Technical Dossier

Compilation or verification of the Technical Documentation.

05EU-Typeexamination

SubmitTechnical Documentation to the Notified Body in order to obtain the EU-typeexamination certificate.

06EU Declaration of Conformity/CE marking

Draw up the EU Declaration of Conformity and provide instructions for affixing the CE marking.

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