Do your images and symbols comply?
Over the last few posts, we have been touching upon different labelling requirements set by the MDR. The use of harmonized and internationally recognized symbols is another labeling related Medical Device Regulation (MDR) requirement that primarily corresponds with ISO 15223 requirements. Instructions for Use (IFU) related updates of explanations of graphical symbols must be made, if not made already.
It is advantageous for manufacturers that the regulation does not require a description for each graphical symbol on the label, as this saves space. However, the use of symbols without explanation appears to be in contradiction with another MDR requirement that states user documentation must be easily understandable. Therefore, MDR requires symbols be explained in the IFU and this implies that the IFU must be updated. That the information in labeling must be readily understood by the intended user is emphasized in several sections of the MDR, and manufacturers are encouraged to improve their instructions with drawings and diagrams.
All this information must be understandable to the Healthcare Professional as well as the non-expert user and patient. In addition to reports and observations from post-market surveillance, periodic updates from clinical trials will also add a layer of complexity. This will necessitate systematic and thorough update approaches throughout the product lifecycle.
Once your IFU is updated to comply with MDR requirements, you will still need several cycles of verifications and comparisons to successfully exit the labyrinth of updates required to finalize your documents. At this point, a reliable proofreading software can prove invaluable. Schlafender Hase’s TVT (Text Verification Tool®) will help you identify mistakes very quickly and create consistency among diagrams, documents, sets of labeling items or among entire product groups. TVT is a text and graphic verification software that ensures only approved content is printed or published.
