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: 33259–34794

3         a notified body within the meaning of Council Directive 90/385/EEC         (a) for a medical device that the manufacturer intends to be supplied in a sterile state (whether or not it has a measuring function), either of the following:
                                                                                       (i) a complete quality assurance system certificate or other document issued under section 3 of Annex 2 of Council Directive 90/385/EEC; or
                                                                                       (ii) an assurance of production quality certificate or other document issued under Annex 5 of Council Directive 90/385/EEC;
                                                                                     (b) for a medical device that has a measuring function (and that the manufacturer intends to be supplied in a non-sterile state), one of the following:
                                                                                       (i) a complete quality assurance system certificate or other document issued under section 3 of Annex 2 of Council Directive 90/385/EEC;
                                                                                       (ii) an EC verification certificate issued under Annex 4 of Council Directive 90/385/EEC; or
                                                                                       (iii) an assurance of production quality certificate or other document issued under Annex 5 of Council Directive 90/385/EEC