Informal collection of national requirements in EU
Within the transition into (EU) 2017/745 MDR, some EU27 member states will implement national laws and additional requirements. The file attached gives an overview of the current status. Important: This table is a collection of informal information and is surly not complete and up-to-date. Whenever you notice an error on an outdated information, just let me know and I’ll update.
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....http://www.plainlanguage.gov/index.cfm
Comparison of TD structure as per STED versus MDD versus ToC
Medical device manufacturers acting globally should decide carefully about the structure of their technical documentation. Setting up the right format will prevent redundant documentation and non-value adding expenses. The document attached gives a generic overview of STED, MDR and ToC formats. It can be seen, that all three approaches are pretty equivalent. For sure, differences can be found when diving deeper into details and requirements.
Attached files:
Informal collection of national requirements in EU
Flesch Reading Ease Test
Good Technical Documentation
Comparison of TD as per STED, MDR and ToC
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