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The Active Implantable Medical Devices (Amendment and Transitional Provisions) Regulations 1995
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- UK Statutory Instruments
- 1995 No. 1671
- Regulation 8
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Insertion of regulation 7A into the principal Regulations
8. 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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