Document ID: chunk:federal_register_of_legislation:F2025C00024:clause:3_7:p1
Version: federal_register_of_legislation:F2025C00024
Segment Type: clause
Provision Reference: sch 3 cl 7 (pt 1/2)
Character Range: 23361–26107

7  Kind of information—medical devices used for a special purpose that are a system or procedure pack

        (1A) An application for a medical device used for a special purpose that is a system or procedure pack and:
           (a) classified under the Regulations as a Class I medical device that:
              (i) does not have a measuring function; and
              (ii) the manufacturer intends to be supplied in a non-sterile state; or
           (b) classified under the Regulations as a Class 1 IVD medical device; or
           (c) intended by the manufacturer to be for export only;

       must be accompanied by the following kind of information:
           (d) a declaration of conformity that relates to the manufacturer's quality management system specified in column 3 of an item in the table in Division 1 of Part 1 of Schedule 3, which is recognised by the regulatory authority in column 2 of that item; and
           (e) a conformity assessment document in relation to each medical device contained in the system or procedure pack specified for that item in column 4 (if any), which is issued or recognised by the regulatory authority in column 2 of that item.

        (1) An application for a medical device used for a special purpose that is a system or procedure pack, other than a medical device that is mentioned in subsection (1A), must be accompanied by the following kind of information:
           (a) a declaration of conformity that relates to the manufacturer's quality management system specified in column 3 of an item in the table in Division 2 of Part 1 of Schedule 3, which is recognised by the regulatory authority in column 2 of that item; and
           (b) a conformity assessment document in relation to each medical device contained in the system or procedure pack specified for that item in column 4 (if any), which is issued or recognised by the regulatory authority in column 2 of that item.
Additional information required where the manufacturer intends the medical device used for a special purpose to be supplied in a sterile state
 (2) An application for a medical device to which subsection (1) applies, and which the manufacturer intends to be supplied in a sterile state, must also be accompanied by the following kind of information:
 (a) a conformity assessment document that relates to the manufacturer's quality management system specified in column 3 of an item in the table in Part 2 of Schedule 3, which is issued or recognised by the regulatory authority in column 2 of that item; and
 (b) a conformity assessment document that relates to product assessment specified for that item in column 4 (if any), which is issued or recognised by the regulatory authority in column 2 of that