Risk categories of PPE
Article 18
The PPE shall be classified according to the risk categories set out in Annex I.
Regulation (EU) 2016/425 CHAPTER IV — CONFORMITY ASSESSMENT
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Conformity assessment procedures
Article 19
The conformity assessment procedures to be followed for each of the risk categories set out in Annex I are as follows: (a) Category I: internal production control (module A) set out in Annex IV; (b) 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; (c) Category III: EU type-examination (module B) set out in Annex V, and either of the following: (i) conformity to type based on internal production control plus supervised product checks at random intervals (module C2) set out in Annex VII; (ii) 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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