2023-09-13T05:26:51
2.0 Device description and product specification, including variants and accessories
2.1 The dossier should contain the following descriptive information for the device:—
(a) A general description including its generic name, model name, model No., materials of construction, intended use, indications,
44[instructions for use or electronic instructions for use], contraindications, warnings, precautions and potential adverse effects;
(b) the intended patient population and medical condition to be diagnosed or treated and other considerations such as patient selection criteria;
(c) principle of operation or mode of action, accompanies by
animation or videos (if available);
(d) an explanation of any novel features;
Have a question? Ask here!
Required fields are marked *