- Latest available (Revised)
- Original (As made)
This is the original version (as it was originally made). UK Statutory Instruments are not carried in their revised form on this site.
4.—(1) Subject to paragraph (2), no fee shall be payable in connection with services provided in respect of a notice relating to a device where the manufacturer has previously given notice in relation to that device.
(2) A fee shall be payable where the investigation plan forming part of the statement accompanying the notice in accordance with regulation 7(1) of the 1992 Regulations or regulation 16(1)(a) of the 1994 Regulations differs from the plan submitted with the immediately preceding notice in that it includes:—
(a)a change to the number of patients or devices forming the basis of the proposed trial,
(b)a change or extension in the indications for use of the device or to the purpose or objectives of the trial,
(c)a change in any of the materials used in the device that come into direct contact with the human body if the new materials are not known to be biocompatible,
(d)a change in the design of the device involving a novel feature not previously tested being a change that has a direct effect on a vital physiological function.