Language Requirements
With a growing European Union we observe an increase in the mandatory requirements of national languages needed for labelling of medical devices. Also other countries in the global medical device market are requesting their national languages in labelling.
Readability of Labeling
Several comments were made in the past with regard to simplicity in labeling, especially in Home care. Patient information (like Instructions for use) was often found to be too complex and difficult to understand for home care users. Tools are available to validate if language used in labelling is too complex or easy to understand. One tool is the “Flesch Reading Ease Test”.
Plain Language Guidelines
The Plain Language Action and Information Network (PLAIN) is a community of federal employees dedicated to the idea that citizens deserve clear communications from government. FDA first developed this document in the mid-90s. FDA continues to revise it every few years to provide updated advice on clear communication. FDA hopes you find this document useful, and that it helps you improve your writing — and your agency’s writing — so your users can find what they need, understand what they find; and use what they find to meet their Needs. The document can be found under....
Attached files:
Requirements for national languages
Flesch Reading Ease Test
Good Technical Documentation
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