Paragraph 2 Amendment of regulation 3 (amendment of Part I of the 2002 Regulations)I1

for paragraph (1), substitute—

“(1)

In F1Parts II, III and IV of these Regulations, a “designated standard” means—

(a)

a technical specification which is—

(i)

adopted by a recognised standardisation body, for repeated or continuous application with which compliance is not compulsory; and

(ii)

designated by the Secretary of State by publishing a reference to the standard and maintaining that publication in a manner the Secretary of State considers appropriate; or

(b)

a monograph of the European Pharmacopoeia (in particular on surgical sutures and on the interaction between medicinal products and materials used in devices containing medicinal products) which has been published in the Official Journal of the European Union.”;

in paragraph (3)(b), for “(CENLAC)” substitute, “ (CENELEC) ”;

for paragraph (8), substitute—

“(8)

In this regulation—

(a)

a reference to a “device” is a reference to a medical device or its accessory or an in vitro diagnostic medical device or its accessory to which these Regulations apply;

(b)

a reference to “the European Pharmacopoeia” is a reference to the European Pharmacopoeia adopted in accordance with the Convention on the Elaboration of a European Pharmacopoeia.”M1.