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

This section has no associated Explanatory Memorandum

25.  In Article 4(extension of renewal of designation)—

(a)in paragraph 1, for “notified” substitute “approved”;

(b)in paragraph 2, for “notified” substitute “an approved”;

(c)for paragraph 5, substitute—

5.  An approved body, within the meaning of regulation A45(1)(b) of the Medical Devices Regulations 2002, whose designation does not have a stated validity period or has a validity period exceeding five years, is to be subject to a renewal within five years of IP completion day.