Tag: instructions
Electronic instructions for the use of medical devices
EU Regulation 2017/745 (MDR) specifies the general requirements for instructions for use (IFU for short). The Implementing Regulation (EU) 2021/2226 regulates whether it can also be available in electronic format (eIFU). We have summarized the requirements of the electronic operating instructions for you. 1. Requirements for using the electronic operating instructions According to Implementing Regulation…
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