8.—(1) Annex 17 (restrictions on the manufacture, placing on the market and use of certain dangerous substances, mixtures and articles) is amended in accordance with this regulation.
(2) In entry 51 (Bis(2-ethylhexyl) phthalate (DEHP) etc.)(1), in the second column, in paragraph 4(g)—
(a)before “medical devices” insert “relevant”;
(b)omit “within the scope of the Medical Devices Regulations 2002”.
(3) In entry 68 (perfluorooctanoic acid)(2), in the second column—
(a)in paragraph 3(c)—
(i)after “2032 to” insert “relevant”,
(ii)omit “within the scope of the Medical Devices Regulations 2002”;
(b)in paragraph 4(d)(i)—
(i)after “implantable” insert “relevant”,
(ii)omit “within the scope of the Medical Devices Regulations 2002”;
(c)in paragraph 6(b), after “implantable” insert “relevant”.
(4) In entry 72 (the substances listed in column 1 of the table in Appendix 12)(3), in the second column, in paragraph 4, after “of the Council” insert “, Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices as it has effect in EU law”.
(5) In entry 74 (diisocyanates etc.), in the second column—
(a)for paragraph 6 substitute—
“6. The training:
(a)must comply with any other requirements contained in any other legislation that relate to the delivery of the training elements referred to in paragraph 5, and
(b)is in addition to any other training required by any other legislation.”;
(b)in paragraph 7, omit the words from “in the official” to the end of the first sentence;
(c)in paragraph 9, in the opening text—
(i)for “Member States” substitute “The Agency”,
(ii)for “their reports” substitute “its report”,
(iii)for “117(1)” substitute “117(2)”;
(d)in paragraph 9, omit subparagraphs (a) and (c);
(e)in paragraph 10, omit “Union”.
Entry 51 was amended by S.I. 2019/1144 as amended by S.I. 2020/1577.
Entry 68 was amended by S.I. 2019/758.
Entry 72 was amended by S.I. 2019/1144 as amended by S.I. 2020/1577.