Blog · 10 February 2026
“Is our device class even eligible for eIFU?” is one of the most common questions manufacturers ask. The short answer since 16 July 2025: the risk class no longer decides — the intended user does. If the device is intended for professional users, electronic instructions are an option for every class. Here is what that means in practice.
| Device category | Can it use eIFU? | Notes |
|---|---|---|
| Class I (incl. Is, Im, Ir) | Yes, for professional use | IFU may even be omitted entirely if the device can be used safely without it (MDR Annex I, 23.1(d)) |
| Class IIa | Yes, for professional use | Same IFU exemption option as Class I; otherwise standard eIFU conditions apply |
| Class IIb | Yes, for professional use | Standard eIFU conditions; risk assessment reviewed as part of technical documentation |
| Class III & implantable | Yes, for professional use | eIFU was possible for implantables already under the original 2021/2226; implant card and patient information duties remain separate |
| Annex XVI products (no medical purpose) | Yes, for professional use | Explicitly covered since Regulation (EU) 2025/1234 |
| Legacy devices (MDR transitional provisions) | Yes, for professional use | Covered by Regulation (EU) 2025/1234 |
| Any class intended for lay users | No | Paper instructions remain mandatory for consumers; dual-use devices need paper for the lay-user information |
The class no longer limits whether you may use eIFU, but it shapes how the switch is scrutinised. Class I is self-certified — the risk assessment required by Regulation (EU) 2021/2226 stays your own responsibility. From Class IIa upwards, a notified body reviews the technical documentation, so the eIFU risk assessment should be audit-ready. For Class III and implantable devices expect the closest scrutiny — and remember that implant cards and patient-facing information follow their own MDR rules and cannot be replaced by eIFU.
The conditions of Regulation (EU) 2021/2226 are class-independent: a documented risk assessment, instructions available on your website in a common format, clear access information on the label (URL, REF/UDI code), a free paper copy on request, and availability of all versions for the prescribed period. Read the details in our guide What is eIFU or the summary of Regulation (EU) 2025/1234.
In vitro diagnostic devices follow their own regulation (IVDR 2017/746), which permits providing instructions electronically for professional-use IVDs under its own conditions — Regulation (EU) 2021/2226 formally covers MDR devices. If your portfolio mixes both, treat the two regimes separately.
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