# The Active Implantable Medical Devices (Amendment and Transitional Provisions) Regulations 1995, Regulation 8: Insertion of regulation 7A into the principal Regulations


After regulation 7 of the principal Regulations (clinical investigations) there shall be inserted the following regulation—
“Obligations of persons other than manufacturers
7A (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.”.

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Source: https://www.legislation.gov.uk/uksi/1995/1671/regulation/8 (the official version)
Page: https://openlegislation.uk/active-implantable-medical-devices-amendment-and-transitional-provisions-regulations-1995/regulation-8
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.