Document ID: chunk:federal_register_of_legislation:F2019L00426:clause:3_6
Version: federal_register_of_legislation:F2019L00426
Segment Type: clause
Provision Reference: sch 3 cl 6
Character Range: 3477–4546

6  Conformity assessment standardsquality management systems for kinds of medical devices intended to be supplied in a sterile state
 (1) This section applies in relation to the manufacture of a kind of medical device that is intended by the manufacturer to be supplied in a sterile state.
 (2) The matters specified in a standard, or part of a standard, mentioned in column 2 of an item in the table in Schedule 2 to this instrument, when used for a purpose mentioned in column 3 of that item, constitute a conformity assessment standard for a quality management system mentioned in Part 1 or 4 of Schedule 3 to the Regulations.
 (3) A quality management system mentioned in Part 1 or 4 of Schedule 3 to the Regulations that complies with a standard, or part of a standard, mentioned in column 2 of an item in the table in Schedule 2 to this instrument, when that standard is used for the purpose mentioned in column 3 of that item, is to be treated as having had applied to it those parts of the conformity assessment procedures specified in column 4 of that item.