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”.