(c)

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

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.