SCHEDULE 1 Amendment of the Medical Devices Regulations 2002

Insertion of regulation 47A

17.  After regulation 47 (general matters relating to UK notified bodies) insert—

“Register of UK notified bodies

47A.— (1) The Secretary of State must ensure that—

(a) each notified body established in the United Kingdom is assigned an identification number; and

(b) there is a register of—

(i) notified bodies established in the United Kingdom;

(ii) their notified body identification number;

(iii) the tasks for which they have been notified;

(iv) any restrictions on those tasks.

(2) The Secretary of State must ensure that the register referred to in paragraph (1) is maintained and made publicly available.

(3) The Secretary of State may authorise the United Kingdom Accreditation Service to compile and maintain the register in accordance with paragraph (1)(b).”.