The Medical Devices (Amendment) (EU Exit) Regulations 2021

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”.