Regulation 15 Procedures for custom-made general medical devicesE1

England, Wales and Scotland

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 F1their UK responsible person—

(a)

has drawn up a statement containing the information required by Sections 1, 2 and 2.1 of Annex VIII F2, read with Regulation (EU) No 722/2012;

(b)

has undertaken to keep available for the Secretary of State documentation allowing an understanding of the design, manufacture and performances of the device, including the expected performances, so as to allow assessment of conformity of the device with the requirements of Directive 93/42; and

(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 VIII; F3...

(d)

keeps available for the Secretary of State, for a minimum period of five years, the information contained in the statement referred to in paragraph (a) and in the undertaking referred to in paragraph (b) F4; and

(e)

ensures that the statement is passed on with the custom-made device so that it may be made available to the patient on request.

Annotations

Textual amendments

F1: Words in reg. 15 substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 4(7C) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 19); 2020 c. 1, Sch. 5 para. 1(1)
F2: Words in reg. 15(a) inserted (21.10.2013) by The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 5
F3: Word in reg. 15(c) omitted (21.3.2010) by virtue of The Medical Devices (Amendment) Regulations 2008 (S.I. 2008/2936), regs. 1(1), 8(1)
F4: Reg. 15(e) and word inserted (21.3.2010) by The Medical Devices (Amendment) Regulations 2008 (S.I. 2008/2936), regs. 1(1), 8(2)

Extent

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