21Records of compliance with applicable standard

21 Records of compliance with applicable standard

For paragraph 20(1)(c), the records are: (a) the test report showing that the device conforms with the applicable standard; and (b) for a variant of the device—a statement by the supplier that: (i) identifies the device and the variant; and (ii) describes the differences between the device and the variant; and (iii) includes an explanation of how the differences mentioned in subparagraph (ii) do not affect the variant’s conformity with the applicable standard.