reg 28 Procedures for custom-made active implantable medical devices
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 their UK responsible person — (a) has drawn up the statement containing the information required by Section 2.1 of Annex 6 , 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).