Document ID: chunk:federal_register_of_legislation:F2025C00024:clause:1_2
Version: federal_register_of_legislation:F2025C00024
Segment Type: clause
Provision Reference: sch 1 cl 2
Character Range: 37901–39607

2          a notified body within the meaning of Council Directive 93/42/EEC           (a) for a medical device that the manufacturer intends to be supplied in a sterile state, either of the following:
                                                                                         1.       a full quality assurance system certificate or other document issued under Annex II of Council Directive 93/42/EEC, excluding section 4 of that Part; or
                                                                                         2.  a production quality assurance certificate or other document issued under Annex V of Council Directive 93/42/EEC;
                                                                                       (b) for a medical device that the manufacturer intends to be supplied in a non-sterile state, one of the following:
                                                                                          1.       a full quality assurance system certificate or other document issued under Annex II of Council Directive 93/42/EEC, excluding section 4 of that Part;
                                                                                         2.  an EC verification certificate issued under Annex IV of Council Directive 93/42/EEC;
                                                                                         3.   a production quality assurance certificate or other document issued under Annex V of Council Directive 93/42/EEC; or
                                                                                         4.   a product quality assurance certificate or other document issued under Annex VI of Council Directive 93/42/EEC