module b: Type-Examination

Type examination is the part of a conformity assessment procedure in which an Approved Body examines the technical design of PPE and verifies and attests that the technical design of the PPE meets the requirements of the Regulation that apply to it.

This is an option for PPE  Risk Category II or III. It is carried out by assessment of the adequacy of the technical design of the PPE through: 

  • examination of the technical documentation
  • examination of a sample(s), representative of the production envisaged, of the complete PPE (production type).

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Technical File

This documentation is the key information of the PPE, it describes design, construction, components, functions and instructions for users. All the requirements are listed in the application form. Click here to download. 


It may be attached through single or several files, folders or a portfolio and include drawings, sketches, designs, colours, shapes and indications. 

article 12

When the manufacturer’s obligations apply to importers or distributors who wish to place PPE on the market under their name or brand, the documents in Resources must be submitted to Alienor Certification with the application. 

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