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.”.