Document ID: chunk:federal_register_of_legislation:F2025C00024:clause:1_4
Version: federal_register_of_legislation:F2025C00024
Segment Type: clause
Provision Reference: sch 1 cl 4
Character Range: 47772–49218

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