Labeling

Q: Can I use eIFU for any EU device?

From June/July 2025, eIFU may be supplied for all professional-use devices (including Annex XVI) if regulatory conditions are satisfied. If the device may be used by lay persons, the IFU for lay users must be provided on paper.

Q: Does FDA allow e-labeling?

FDA allows electronic formats in certain contexts, but device labeling must comply with 21 CFR 801. There is no EU-style blanket eIFU rule; ensure users can access required information and that electronic content is truthful, not misleading, and consistent with cleared/approved labeling.

Q: Do symbols eliminate the need for text?

Stand-alone symbols may be used when conditions are met (FDA symbols rule; ISO 15223-1), but users must still be able to understand the information; explain symbols in the IFU when not widely recognized.

Q: What should my website include for EU eIFU?

Official-language IFUs viewable with free software, integrity and version controls, clear access instructions, and a contact path for paper copies—supported by a documented risk assessment, cybersecurity, and availability controls.

Labeling is all information supplied with a medical device to enable safe and effective use, including the device label, packaging labels, instructions for use (IFU)/user manual, warnings, symbols, and—where permitted—electronic instructions for use (eIFU). Labeling content, format, and accessibility are regulated to ensure clarity, accuracy, and consistency across markets.

EU MDR Annex I Ch. IIIFDA 21 CFR 801ISO 15223-1 • ISO 20417

What labeling must include (core elements)

Device identification: name, model, lot/serial, and UDI carrier where required.
Manufacturer & economic operators: manufacturer address, EU AR (if applicable), importer.
Intended purpose & user profile: indications, target users/environments, contraindications.
Safety information: warnings, precautions, residual risks, storage/handling, shelf life.
IFU/Manual: installation, operation, maintenance, disposal; eIFU allowed under defined conditions.
Symbols & language: standardized symbols (ISO 15223-1) and required languages per market.

Latest: EU rules on electronic IFU (e-labeling)

EU Implementing Regulation (EU) 2021/2226, as amended by (EU) 2025/1234, expands when IFUs may be provided electronically instead of paper.

Scope expansion (2025/1234): eIFU may be provided for all medical devices for professional use (including Annex XVI non-medical purpose devices) when conditions are met; if a device may also be used by lay persons, the IFU intended for lay users must be supplied in paper form.
Risk assessment: manufacturers must perform and maintain a documented risk assessment showing eIFU maintains or improves safety versus paper (e.g., website downtime, emergency access, cybersecurity, version control).
Paper on request: provide paper IFU free of charge within the defined timeframe and no later than 7 calendar days after request (or at delivery if requested at order).
Website requirements: IFU must be on the manufacturer’s website in required EU languages, in a commonly used file format viewable with freely available software; site must ensure integrity, availability, and version history; certain media (e.g., video/audio) may supplement but not replace the text.
Software devices: software may provide the IFU electronically within the software itself; manufacturers must still meet the website and risk-control requirements.

Tip: Clearly inform users on packaging/device where to access the eIFU and how to request a paper copy; keep the eIFU synchronized with the technical documentation and GSPR matrix.

Other jurisdictions (quick view)

United States (FDA): Labeling requirements are in 21 CFR Part 801 (definitions, content, prominence, UDI). FDA does not have a single “eIFU regulation” like the EU, but permits electronic formats in defined contexts; any electronic labeling must still meet Part 801, be truthful/non-misleading, and ensure users can access required information. FDA also permits stand-alone symbols under specified conditions.
Australia (TGA): eIFU is permitted for eligible professional-use devices if specific conditions are met (e.g., access, risk assessment, paper on request); consumer products generally still need paper IFU.

Best practices for compliant, usable labeling

Adopt ISO 20417 for information requirements and ISO 15223-1 for symbols to support global acceptance.
Run readability/usability checks; align IFU with risk controls, intended purpose, and verification/validation evidence.
Control labeling under your QMS (change control, translations, versioning); keep the website eIFU and packaging pointers up-to-date.
For eIFU: monitor uptime, security, and archive/version history; state a contact path for paper copies and adverse event reporting.

Labeling — FAQs

Can I use eIFU for any EU device?

From June/July 2025, eIFU may be supplied for all professional-use devices (including Annex XVI) if the regulatory conditions are satisfied. If the device may be used by lay persons, the lay IFU must still be provided on paper.

How fast must I send a paper IFU on request in the EU?

At no cost and within the timeframe in your risk assessment, but not later than 7 calendar days after receiving the request (or at delivery if requested at order).

Does FDA allow e-labeling?

FDA allows electronic formats in certain contexts, but U.S. device labeling must comply with 21 CFR 801. There is no EU-style blanket eIFU rule; ensure users can access required information and that electronic content is truthful, not misleading, and consistent with cleared/approved labeling.

Do symbols eliminate the need for text?

Under FDA’s symbols rule and ISO 15223-1, stand-alone symbols can be used when conditions are met, but clarity for intended users is paramount; where not widely recognized, explain symbols in the IFU.

What should my website include for EU eIFU?

Official-language IFUs in a common, freely viewable format; integrity and version controls; clear access instructions; and contact details for paper copies. Ensure cybersecurity and availability controls per your documented risk assessment.

e-Labeling / eIFU — at a glance

Jurisdiction	Scope	Paper IFU	Website & Access	Notes
EU (MDR)	eIFU allowed for all professional-use devices (incl. Annex XVI) when conditions met; not for lay-use IFU.	Must supply paper on request free of charge ≤ 7 days; if requested at order, include at delivery.	IFU hosted in required languages; common, free viewer format; integrity, availability, version history required.	Implementing Reg. (EU) 2021/2226 as amended by (EU) 2025/1234; documented risk assessment is mandatory.
U.S. (FDA)	No blanket eIFU rule; electronic formats permitted in defined contexts; must meet 21 CFR 801.	Paper may still be required depending on device, users, and use environment; ensure reasonable user access.	Electronic content must be truthful, not misleading, consistent with cleared/approved labeling; ensure availability.	Consider symbols rule; align with UDI/part 801 prominence and readability expectations.
Australia (TGA)	eIFU permitted for eligible professional-use devices when conditions are satisfied.	Provide paper on request at no cost within defined timeframe.	Accessible website, language/format requirements, availability and version control expected.	Follow Essential Principles; ARTG inclusion still requires compliant labeling set.

Tip: Add a clear on-pack notice pointing to the eIFU URL/QR and the process to request a paper copy.
Compliance: Keep the eIFU version-controlled and synchronized with your technical documentation and change control.