Topic outline



    Conformity assessment procedures

    The manufacturer is responsible for the conformity assessment for the PPE during the design and manufacturing stages.

    If the importer or distributor puts PPE on sale under its own trade name or trademark, the obligations of the manufacturer apply to the importer or distributor (for further details, see the “Obligations of businesses” section under the “Private label” heading). In this case, the importer or distributor must apply jointly for an EU-type examination certificate for the PPE with the original manufacturer.

    The conformity assessment procedures are determined by the risk category of the PPE. The conformity assessment procedures for the different risk categories are presented in the table below.

    Risk category

    Conformity assessment procedures

    Category I

    Internal production control

    (module A)

    Category II

    EU-type examination (module B) and

    Internal production control (module C)

    Category III

    EU-type examination (module B) and either internal production control plus random product checks (module C2) or quality assurance of the production process (module D)

    The different modules are described in Annexes IV–VIII to the PPE Regulation (EU) 2016/425.

    For Category I products, it is sufficient that the manufacturer compiles the technical documentation and assesses the conformity of the product themselves. For products in Categories II and III, the notified body must be involved in the conformity assessment, and for Class III products, the notified body must also be involved in the quality control during production. For more information on the conformity assessment procedures and the modules to be used, please refer to the headings “EU-type examination” and “quality control during production”.