Document ID: chunk:federal_register_of_legislation:F2025C00024:clause:1_6
Version: federal_register_of_legislation:F2025C00024
Segment Type: clause
Provision Reference: sch 1 cl 6
Character Range: 59528–60776

6              a notified body within the meaning of Council Directive 90/385/EEC          1.      for a medical device that the manufacturer intends to be supplied in a sterile state:                                                                                                                                      an EC type-examination certificate issued under Annex 3 of Council Directive 90/385/EEC
                                                                                             1.       an assurance of production quality certificate or other document issued under Annex 5 of Council Directive 90/385/EEC;
                                                                                           1.     for a medical device that the manufacturer intends to be supplied in a non-sterile state, either of the following:
                                                                                             1.       an EC verification certificate issued under Annex 4 of Council Directive 90/385/EEC; or
                                                                                             2.     an assurance of production quality certificate or other document issued under Annex 5 of Council Directive 90/385/EEC