Paragraph 16

In Annex II (which relates to summary evaluation reports)—

(a)

in the table headed “Details relating to the submitting notified body”—

(i)

for the heading substitute “Details relating to the submitting approved body”,

(ii)

in entry 1 for “notified body” substitute “approved body”,

(iii)

in entry 2 for “Notified body” substitute “Approved body”,

(iv)

in entry 10, for the stem substitute—

“Confirmation that the submitting approved body has been designated by the Secretary of State for the conformity assessment of”;

(b)

in the box headed “Notified Body Statement”—

(i)

for the heading substitute “Approved Body Statement”,

(ii)

for “Council Directive 90/385/EEC” substitute “Part 3 of the Medical Devices Regulations 2002”,

(iii)

for “Council Directive 93/42/EEC” substitute “Part 2 of the Medical Devices Regulations 2002”.