Document ID: chunk:federal_register_of_legislation:F2025C00024:clause:1_3
Version: federal_register_of_legislation:F2025C00024
Segment Type: clause
Provision Reference: sch 1 cl 3
Character Range: 39607–41095

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