What is a requirement for providing electronic Instructions for Use (eIFUs)?
Answer
The delivery method must remain reliable and accessible within the professional setting.
While digital formats offer benefits like easier updates, reliability is paramount in a professional environment. If the method of access, such as a QR code or website, fails in a high-pressure clinical situation, it could constitute a safety issue or a labeling violation. Access must be immediate and consistent to ensure safe device operation.
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