# 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), Article 19: Conformity assessment procedures

Extent: E+W+S+N.I.

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: ... 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: ... 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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Source: https://www.legislation.gov.uk/eur/2016/425/article/19 (the official version)
Page: https://openlegislation.uk/eu-regulation-2016-425/article-19
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.