SCHEDULE 2Amendments to EU tertiary legislation

PART 1

Amendments to Commission Decision 2002/364/EC

3

In the Annex (which contains common technical specifications for in vitro diagnostic medical devices)—

a

in point 3.1.4—

i

for “CE marking” substitute “UK or CE marking”,

ii

for “CE marked” substitute “UK or CE marked”;

b

in point 3.1.8.—

i

for “CE marked” substitute “UK or CE marked,”,

ii

for “notified body” substitute “approved body”;

c

in point 3.4.1—

i

for “CE marking” substitute “UK or CE making”,

ii

for “CE marked” substitute “UK or CE marked”;

d

in Table 1, in the row marked Diagnostic sensitivity, for “Notified Body” in each place substitute “Approved Body”.