Document ID: chunk:federal_register_of_legislation:F2022L01534:clause:1_1
Version: federal_register_of_legislation:F2022L01534
Segment Type: clause
Provision Reference: sch 1 cl 1
Character Range: 6078–8074

1                                                 the following information provided by a sponsor (or a person authorised to act on behalf of a sponsor) in the online notification form in relation to the transition of a relevant kind of medical device, as applicable:
                                                    (a) the manufacturer's name;
                                                    (b) the sponsor's name;
                                                    (c) contact details for enquiries;
                                                    (d) the name of the kind of medical device affected by the transition;
                                                    (e) the device number;
                                                    (f) the GMDN code;
                                                    (g) the GTIN;
                                                    (h) the intended purpose;
                                                    (i) the date of effect of the EU MDR certificate;
                                                    (j) details of changes in relation to any of the following matters relating to the kind of medical device as a result of the transition (that is, details under the EU MDD certificate, details under the EU MDR certificate and products affected):
                                                       (i) indications in the instructions for use;
                                                       (ii) class of persons for which the device is suitable;
                                                       (iii) intended purpose;
                                                       (iv) functional description;
                                                       (v) addition of a warning for a novel or newly identified safety issue or contraindication;
                                                       (vi) addition of adverse event information that would change patient management recommendations