2 docs tagged with "post-market"

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.

Both MDR 2017/745 and IVDR 2017/746. Post-market obligations begin the moment a device is placed on the market and continue until the device is withdrawn from service.