CHAPTER IV

Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on personal protective equipment and repealing Council Directive 89/686/EEC (Text with EEA relevance) · European Union

The PPE shall be classified according to the risk categories set out in Annex I. The conformity assessment procedures to be followed for each of the risk categories set out in Annex I are as follows: Category I: internal production control (module A) set out in Annex IV; Category II: EU type-examination (module B) set out in Annex V, followed by conformity to type based on internal production control (module C) set out in Annex VI; Category III: EU type-examination (module B) set out in Annex V, and either of the following: conformity to type based on internal production control plus supervised product checks at random intervals (module C2) set out in Annex VII; conformity to type based on quality assurance of the production process (module D) set out in Annex VIII. By way of derogation, for PPE produced as a single unit to fit an individual user and classified according to Category III, the procedure referred to in point (b) may be followed.

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Source: EUR-Lex (Cellar) · retrieved 2026-11-01 · Text as adopted (Official Journal); later amendments are not incorporated in this text.