The Medical Devices Regulations 2002

[F1Obligations in Part IV of these Regulations which are met by complying with obligations in Regulation (EU) 2017/746E+W+S

44ZB.—(1) In this regulation—

(a)any reference to an Article or Annex is a reference to that Article or Annex in Regulation (EU) 2017/746 as it has effect in EU law;

(b)“CE marking” means the CE marking required by Article 18 and presented in Annex V;

(c)“harmonised standard” has the meaning given in Article 2(73);

(d)“sponsor” has the meaning given in Article 2(57).

(2) Where paragraph (3) applies, regulations 34, 36(1) to (4), 37 and 40 are treated as being satisfied.

(3) This paragraph applies where, before placing a relevant device on the market, the manufacturer—

(a)ensures—

(i)that the device meets the general safety and performance requirements in Annex I which apply to it; or

(ii)that paragraphs (6) and (7) apply;

(b)ensures that the relevant conformity assessment procedure that applies to the device has been carried out in accordance with Article 48;

[F2(ba)ensures that any certificate issued by a notified body in connection with that conformity assessment procedure has not expired or been withdrawn;]

(c)ensures that the documentation required by the relevant conformity assessment procedure is drawn up;

(d)ensures that the technical documentation required by Annexes II and III and other relevant documentation required by the relevant conformity assessment procedure is prepared in or translated into English;

(e)affixes a CE marking and, where applicable, the identification number of the notified body which carried out the relevant conformity assessment on the device in accordance with the procedures set out in Annexes IX, X and XI;

(f)draws up an EU declaration of conformity in accordance with Article 17; and

(g)ensures that the declaration of conformity is prepared in or translated into English.

(4) Where paragraph (5) applies, regulation 43 is treated as being satisfied.

(5) This paragraph applies where, before a person supplies or makes available a device falling within Part IV for the purposes of performance evaluation, the sponsor of the performance evaluation—

(a)has been able to provide the Secretary of State with the required notice in the form of the application required by Chapter I of Annex XIV in English;

(b)has been able to provide the Secretary of State with an undertaking to keep available information contained in the application in accordance with Chapter II of Annex XIV.

(6) Where paragraph (7) applies, a relevant device referred to in that paragraph is also treated as complying with the relevant essential requirements referred to in regulation 35(3) and (4).

(7) This paragraph applies where—

(a)a relevant device conforms with a harmonised standard or part of a harmonised standard, which corresponds exactly to a designated standard or part of a designated standard; or

(b)a relevant device is in conformity with a common technical specification.

(8) For the purpose of this regulation, in regulations 36(5), 51 and 61(8), each reference to “UK marking” is to be read as a reference to “CE marking”.]

Textual Amendments