Regulation (EU) 2016/425 of the European Parliament and of the CouncilShow full title

CHAPTER IV U.K. CONFORMITY ASSESSMENT

Article 18 U.K. Risk categories of PPE

The PPE shall be classified according to the risk categories set out in Annex I.

Article 19 U.K. Conformity assessment procedures

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: F1 ... 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: F2 ... 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.

Textual Amendments

F1 Word in Art. 19(b) omitted (31.12.2020) by virtue of The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 35 para. 3(17); 2020 c. 1, Sch. 5 para. 1(1)

F2 Word in Art. 19(c) omitted (31.12.2020) by virtue of The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 35 para. 3(17); 2020 c. 1, Sch. 5 para. 1(1)