PART 2PLACING PRODUCTS ON THE MARKET
MISCELLANEOUS
F1Conformity assessment procedure obligation which is met by complying with the Directive40B
1
In this regulation any reference to an Article or an Annex is a reference to an Article of or Annex to the Directive.
2
Paragraph (3) applies where—
a
Articles 20 or 21 provide that the conformity assessment procedure referred to as Module B in those Articles may be carried out in relation to a product; and
b
prior to the manufacture of a product, the manufacturer ensures that—
i
the product has been designed in accordance with the essential requirements set out in Annex I to the Directive;
ii
the conformity assessment procedure referred to as Module B in Articles 20 and 21 has been carried out in relation to that product, in accordance with those Articles and with Article 24(1).
3
Where this paragraph applies—
a
the requirement in regulation 42 to apply the conformity assessment procedure referred to in regulations 44 and 45 as Module B is to be treated as being satisfied in relation to that product;
b
any reference to “relevant conformity assessment procedure” in regulations 9, 10(1), 19(1)(a), 36(4), 40(1)(b) and 53(b) is to be read as including the conformity assessment procedure referred to in Articles 20, 21 and 24 as Module B; and
c
any reference to “technical documentation” in regulations 9(b), 11, 19(1)(b), 25(b) and 36(3) is to be read as including the technical documentation relating to the design of the product referred to in Article 25 of the Directive;
d
the reference to “approved body” in regulation 36(4) is to be read as the body that undertook the conformity assessment procedure referred to as Module B in Articles 20 or 21.