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

This section has no associated Explanatory Memorandum

31.  In Annex I (which relates to interpretation of the conformity assessment body criteria) —

(a)in section 1.3(b)—

(i)for “authorised representative” substitute “UK responsible person”,

(ii)omit “Union”;

(b)omit section 1.5.