The Medical Devices Regulations 2002 No. 618

PART III U.K. Active Implantable Medical Devices

Procedures for custom-made active implantable medical devices E+W+S

28.  No person shall supply a custom-made device (if that supply is also a placing on the market, or if that supply is of a custom-made device that has been placed on the market) unless its manufacturer or [F1 their UK responsible person]—

(a) has drawn up the statement containing the information required by Section 2.1 of Annex 6[F2 , read with Regulation (EU) No 722/2012];

(b) has undertaken to keep available for the Secretary of State the documentation referred to in Section 3.1 of Annex 6;

(c) takes all necessary measures to ensure that the manufacturing process ensures that each device manufactured according to that process conforms to the documentation referred to in the first paragraph of Section 3.1 of Annex 6; and

(d) keeps available for the Secretary of State the information contained in the statement referred to in paragraph (a) and in the undertaking referred to in paragraph (b).

Extent Information

E1 This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

F1 Words in reg. 28 substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 5(5B) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 paras. 2, 30); 2020 c. 1, Sch. 5 para. 1(1)

F2 Words in reg. 28(a) inserted (21.10.2013) by The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 12

Procedures for custom-made active implantable medical devices N.I.

28.  No person shall supply a custom-made device (if that supply is also a placing on the market, or if that supply is of a custom-made device that has been placed on the market) unless its manufacturer or his authorised representative—

(a) has drawn up the statement containing the information required by Section 2.1 of Annex 6[F3 , read with Regulation (EU) No 722/2012];

(b) has undertaken to keep available for the Secretary of State the documentation referred to in Section 3.1 of Annex 6;

(c) takes all necessary measures to ensure that the manufacturing process ensures that each device manufactured according to that process conforms to the documentation referred to in the first paragraph of Section 3.1 of Annex 6; and

(d) keeps available for the Secretary of State the information contained in the statement referred to in paragraph (a) and in the undertaking referred to in paragraph (b).

Extent Information

E2 This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

F3 Words in reg. 28(a) inserted (21.10.2013) by The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 12