The Medical Devices Regulations 2002

[F17.  In Annex 6—E+W+S

(a)in Section 1, for “authorised representative established within the Community” substitute “UK responsible person”;

(b)in Section 3 for “the competent national authorities” substitute “the Secretary of State”;

(c)in Section 3.1 for “this Directive” substitute “the Regulations”;

(d)in Section 3.2 for the fourth indent substitute—

“–the results of the risk analysis and a list of the designated standards provided for in regulation 3A of the Regulations, applied in full or in part, and a description of the solutions adopted to satisfy the essential requirements where the standards in regulation 3A of the Regulations have not been applied,”;

(e)in Section 5, in the opening paragraph, for “competent authorities” substitute “Secretary of State”.]

Textual Amendments