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

for paragraph (1), substitute—

“(1)

In Parts II, III, IV, VIII and IX 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.”^f1.

in inserted regulation 4D of the 2002 Regulations (revocations, transitional and saving provisions in respect of the new national registration requirements), for paragraph (10)(b), substitute—

“(b)

that is—

(i)

a relevant device for the purposes of Part IV, other than a device referred to in the lists in Annex II of Directive 98/79 or a device for self-testing, which follows the procedure for CE marking in regulation 40(1); or

(ii)

classified (whether or not Part IX applies in respect of the device) as belonging to Class A, referred to in Schedule 23.”; and

in inserted regulation 4E of the 2002 Regulations (transitional provisions in respect of the European Commission’s UDI database), in paragraph (7), for “Part VIII” substitute, “Part IX”.