Regulatory basis - MDR Art. 7 (claims); MDR Art. 2(24) (intended purpose shaped by advertising); IVDR Art. 7 (IVDR claims). Advertising and promotional materials are part of the "information supplied by the manufacturer" and shape the legal intended purpose of the device.
MDR 2017/745, Annex I, Chapter III, Section 23 and IVDR 2017/746, Annex I, Chapter III, Section 20. These are the labelling and IFU requirements as part of the GSPR. Post-market labelling obligations are covered separately in Labelling & advertising.
Regulatory basis - MDR Annex I §23 / IVDR Annex I §20 (GSPR labelling requirements); MDR Art. 10(11) (labelling obligations on manufacturers). Language requirements vary by member state. Post-market labelling obligations extend to maintaining current labelling as the device and evidence evolve.
Regulatory basis - MDR Art. 27(4)–(6) / IVDR Art. 24(4)–(6) and MDR Annex VI Part C / IVDR Annex VI Part C. These provisions specify where and how the UDI carrier must appear on device labelling.
Both MDR 2017/745 and IVDR 2017/746. UDI requirements are set out primarily in MDR Art. 27 / IVDR Art. 24 and MDR Annex VI / IVDR Annex VI.