Plain-language guides on electronic instructions for use (eIFU), EUDAMED and the costs of paper IFUs, for medical device manufacturers.
Since July 2025 manufacturers may provide electronic instructions for use (eIFU) for all medical devices intended for professional users. What changed, when paper is still required, and what you must still document.
Read the guideWhat paper instructions for use really cost, what electronic IFU (eIFU) adds in obligations, and a checklist for deciding when to switch. Based on Regulations (EU) 2021/2226 and 2025/1234.
Read the guideA practical checklist to evaluate electronic instructions for use (eIFU) software: what the regulations require, questions to ask vendors, red flags and a simple way to run a pilot.
Read the guideWhere EUDAMED registration is mandatory, manufacturers who provide electronic instructions for use must give the internet address of the eIFU. Key dates, what makes a good address and a checklist.
Read the guideSummaries for information only; not legal advice.
