Paragraph 38 Insertion of regulation 6(4A)

After regulation 6(4) insert—

“(4A)

In regulation 36 (CE marking of in vitro diagnostic medical devices)—

(a)

in the heading for “CE marking” substitute “UK marking”;

(b)

for “CE marking” each time those words occur substitute “UK marking”;

(c)

for each reference to “Annex X” substitute “Annex 2 of Regulation 765/2008”;

(d)

for “notified body” each time those words occur substitute “approved body”.”.