WHO Global Model Regulatory Framework for Medical Devices including In Vitro Diagnostic Medical Devices 6.2.2.4-labelling: Provide labels and instructions suited to the intended user and in an accepted language, with intended purpose, contraindications, warnings, identification for traceability, UDI where required and manufacturer and importer details matching registration

What does 6.2.2.4-labelling require?

Labels, instructions for use and other labelling (displays, service manuals, web-based patient information) should tell users how to use the device properly and, where relevant, install, maintain and dispose of it, covering intended purpose, proper use, contraindications, precautions and warnings, in a form suited to the intended user (especially lay persons) and in an official or accepted language. Electronic instructions may be allowed, but printed ones must be supplied on request and for home-use devices. Labels should carry batch, lot or serial identification to support traceability, field safety corrective actions and incident investigation, plus UDI data where required, and the device or its outer pack should identify the manufacturer and, where applicable, the distributor, authorized representative or importer, consistent with the establishment registration. Instructions on decontamination and disposal at end of life should be included.