A
Device Identification
▾B
Classification
▾C
Intended Purpose & Users
▾A complete intended purpose should state: what the device does · target population/condition · intended users · use environment · indications · contraindications & limitations. These must be consistent between the label and the IFU.
D
Device Characteristics
▾E
eIFU Intent
▾§
Official Sources & References
▾The primary sources this tool maps against — EU MDR, the eIFU Implementing Regulations, FDA 21 CFR 801, and the applicable ISO/IEC standards.
- EU MDR (Regulation (EU) 2017/745) — Annex I, Ch. III, §23 (label + IFU)
- Implementing Reg (EU) 2021/2226 — electronic IFU (eIFU)
- Implementing Reg (EU) 2025/1234 — amends 2021/2226 (broadens eIFU to professional-use devices)
- 21 CFR Part 801 — FDA device labeling (incl. 801.5, 801.4, 801.109, 801.128)
- ISO 20417 — information supplied by the manufacturer
- ISO 15223-1 — symbols for information supplied
- ISO 14971 — risk management (residual risks in the IFU)
- IEC 62366-1 — usability engineering (IFU as user interface)
- ISO 17664 — information for reprocessing (reusable devices)
- MDCG guidance — incl. 2019-11 (SaMD), 2021-24 (MDSW), 2019-16 (cybersecurity)
- FDA device labeling · patient labeling & human factors guidance
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ISO 15223-1 symbol glossary
▾Symbol graphics are bundled from the open-source (MIT) medical-device-symbols library (the manufacturer-facing set for these ISO 15223-1 / ISO 7000 / IEC 60417 symbols). Always use the authoritative symbol, exact title and conditions of use from ISO 15223-1:2021.
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EU / EEA language requirements
▾Member States set their own IFU/label language requirements — confirm the current national rule.
| Member State | Official language(s) commonly required |
|---|