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Electronic Instructions for Use
Provision of IFU in electronic form instead of, or in addition to, paper.
Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed September 19, 2026
Definition
EU Regulation 2021/2226 and FDA guidance allow eIFUs for specified professional-use device categories, subject to risk assessment, accessibility, and the right of users to request a paper copy. In the EU, Commission Implementing Regulation (EU) 2021/2226 allows electronic instructions for use only for certain professional-use devices, such as implantables, fixed installed devices and devices with built-in IFU displays, provided a risk assessment is done and paper copies are available on request. In the US, FDA permits electronic labeling for certain prescription devices and IVDs. Websites hosting eIFUs must stay accessible and version-controlled. What the regulation says
Electronic Instructions for Use (eIFU) are permitted for certain professional-use medical devices under EU Regulation 2021/2226 and FDA guidance, provided specific conditions are met, including a thorough risk assessment and ensuring user accessibility. These regulations also mandate that users retain the right to request a paper copy of the Instructions for Use (IFU). Both regulatory bodies emphasize the importance of ensuring the eIFU is readily available, easily navigable, and identical in content to its paper counterpart.What this means in practice
eIFUs reduce environmental impact and enable rapid updates, but require version control, archived prior versions, and reliable hosting infrastructure.Examples
- A surgical instrument manufacturer provides its Instructions for Use digitally on a secure website, accessible via a QR code on the device packaging, fulfilling the requirements for professional-use devices under EU Regulation 2021/2226.
- An in vitro diagnostic company offers eIFUs for its laboratory testing equipment, allowing clinical labs to easily access the latest assay protocols and ensuring compliance with FDA guidance for professional-use devices.
- A dental implant company implements an eIFU system that includes a clear option for dentists to request a printed copy free of charge, as mandated by regulatory requirements.
Common pitfalls
- •Failing to conduct a comprehensive risk assessment for the eIFU system can lead to non-compliance and potential patient harm.
- •Neglecting to provide users with a clear and easily accessible option to request a paper copy of the IFU is a common pitfall.
- •Inadequate version control or an unreliable hosting infrastructure for eIFUs can result in the use of outdated or incorrect information.
- •Assuming all device categories are eligible for eIFU, without verifying specific regulatory allowances, can lead to significant regulatory issues.
- •Not considering the accessibility needs of all users, including those with disabilities, in the design of the eIFU system is a frequent oversight.
Frequently asked questions
The primary benefits of eIFUs include reduced environmental impact by minimizing paper waste and enabling rapid dissemination of updated information to users, ensuring they always have access to the most current instructions.
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510(k) Premarket Notification(510(k))
FDA submission demonstrating a device is substantially equivalent to a legally marketed predicate.
Regulatory
510(k) Summary vs 510(k) Statement
Two alternative disclosure mechanisms in a 510(k) submission, a Summary is public on FDA's website; a Statement promises to share Safety & Effectiveness info on request.
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513(g) Request for Information(513(g))
Formal mechanism to ask FDA whether a product is a device and, if so, its likely classification.
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Abbreviated 510(k)
510(k) variant that relies on FDA guidance, special controls, or recognized consensus standards.
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Sources
3 sourcesSources support the definition or relevant regulatory context, not necessarily every claim on this page. Each is graded against our source-tier hierarchy so you can see what rests on binding law versus commentary.
Tier 1Binding law and standards· 1Tier 2Regulator guidance and consensus· 1Tier 4Trade press and expert commentary· 1
Link health: 3 verified· last checked 2026-06-20
EUR-Lex·1RAPS·1FDA·1
- 1Reg. (EU) 2021/2226 on eIFUTier 1 VerifiedEUR-Lexeur-lex.europa.eu
- 2RAPS Regulatory FocusTier 4 VerifiedRAPSraps.org
- 3FDA - Medical DevicesTier 2 VerifiedFDAfda.gov
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