Labelling requirements
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.
Advertising rules & claims
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.