CE marking

EC type-examination is the process by which products are assessed against the Basic Health and Safety Requirements (BHSRs) of the PPE Directive, or the Essential Health and Safety Requirements (EHSRs) of the PPE Regulation, which they must satisfy before being entitled to bear the CE mark. 

There are primarily two ways of doing this:

  • Satisfy a harmonized European standard.
  • Provide a technical specification which addresses each of the BHSRs relevant to the product.  

Summary of required CE Mark application procedures for different categories

 

CE Mark application procedure

Category I

Simple Design

Category II

Intermediate Design

Category III

Complex Design

Comply with the Basic Health and Safety Requirements √ 
Compile technical documents  
EC type-examination
Product / Quality system control as per the PPE Directive or the PPE Regulation
Write EC Declaration of Conformity
Apply CE mark
Technical file

For Category I items of PPE, a Notified Body is not involved in the CE marking process. 

Category III products are items of PPE which are intended to protect against severe hazards to health, for example, respiratory protection, falls from height and against fire and in particular for the rescue services.  For the NEW PPE Regulation, Category III has been extended to include additional types of PPE; for example, hearing protection, amongst others.  

For Categories II and III, a technical file must be submitted and this must contain sufficient information to satisfy Annex III of the Directive or the Regulation.  If the product is to be certified against a non-harmonized standard, then the file must show how each applicable BHSRs or EHSRs has been addressed, usually by means of a technical specification. 

Manufacturers of Category III items must specify which control method they wish to follow - Articles 11.A or 11.B in the case of the PPE Directive, or Modules C2 or D in the case of the PPE Regulation.

Quality documents

For Category III products, the manufacturer must submit his quality manual and this must outline how the applicable requirements are satisfied.   Quality documents submitted to us in support of CE marking will be endorsed and dated by INSPEC. 

The manufacturer must keep us advised of any significant changes to the certified product, and the quality system, and submit revised documents, as appropriate.  

Product/Quality system surveillance

Article 11A/Module C2 require that the product control system be documented and that products are selected annually for independent testing and assessment for homogeneity.  

Article 11B/Module D require a quality management system to be in operation and that this is initially assessed and then monitored by annual visits to the manufacturer’s premises. Independent annual product testing is not required.

 

CE certificate

The CE certificate includes details of the manufacturer, the product (or family, if appropriate), the specification upon which basis the certificate was issued, the date of issue and INSPEC's details. 

 

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