The Medical Devices Regulations 1994

Obligations of persons other than manufacturers

13.—(1) Subject to paragraph (2), any obligation of a manufacturer under these Regulations shall extend to a person who assembles, packages, processes, fully refurbishes or labels one or more ready-made products or assigns to them their intended purpose as a device with a view to their being placed on the market under his own name.

(2) Paragraph (1) shall not apply to a person who assembles or adapts devices already on the market to their intended purpose for an individual patient.

(3) Where neither the manufacturer nor his authorised representative is established within the Community, the obligation to keep available the technical documentation referred to in Section 6.3 of Annex II or Section 7.4 of Annex III shall fall upon the person responsible for placing on the market the device to which the documentation relates or upon the importer referred to in Section 13.3(a) of Annex I.

(4) Where neither the manufacturer nor his authorised representative is established within the Community, the obligation to keep available the technical documentation referred to in Section 2 of Annex VII shall fall upon the person who places on the market the device to which the documentation relates.