How do manufacturers create MDR- and IVDR-compliant labels and instructions for use?
We develop labeling and instructions for use (IFU) for medical devices and in-vitro diagnostics in line with the labeling requirements of MDR (EU) 2017/745 Annex I Section 23 and IVDR (EU) 2017/746 Annex I Section 20, with standard-compliant symbology per ISO 15223-1, multilingual and directly linkable to the technical documentation. The most common audit finding is not a missing symbol, but a label that cannot be traced back to the risk analysis and the GSPR checklist.
- MedTech
- IVD
Overview
Which labeling requirements do MDR and IVDR impose?
Labeling & IFU for MDR (EU 2017/745) and IVDR (EU 2017/746) · Symbology per ISO 15223-1, EN ISO 20417
Last updated: 2026-06-12
MDR (EU) 2017/745 and IVDR (EU) 2017/746 govern the label and instructions for use in dedicated sections of their Annex I and require a verifiable link to the technical documentation for every mandatory particular. The points where labeling projects most often get stuck:
- MDR Annex I Section 23 (for IVD: IVDR Annex I Section 20) exhaustively lists the minimum particulars for the label and the IFU: from manufacturer identity and UDI to warnings, residual risks and the CE marking with the identification number of the notified body.
- Symbols must be used in accordance with ISO 15223-1; deviating or outdated symbols lead to findings in the conformity assessment procedure.
- The IFU must be available in the official language of every Member State in which the device is made available, up to 24 languages for EU-wide marketing, with the risk of terminological inconsistency across versions.
- Electronic instructions for use (eIFU) are permitted under Regulation (EU) 2021/2226 (for MDR devices; it replaces the earlier Regulation 207/2012) only under defined conditions and predominantly for professional users; for lay users, the paper IFU remains the rule.
- Warnings, contraindications and residual risks on the label must be consistent with the risk analysis per ISO 14971:2019 and the GSPR checklist, not worded in isolation.
Services
How we support you
Labeling Review & Gap Analysis
Comparison of existing labels and IFUs against MDR Annex I Section 23 or IVDR Annex I Section 20 and ISO 15223-1; the result is a gap list per mandatory particular with a proposed correction.
Label and IFU Development
New label drafts and structured instructions for use with all mandatory particulars, symbology per ISO 15223-1 and EN ISO 20417, tailored to the intended purpose and user group.
Symbol and UDI Integration
Standard-compliant symbol legend and correct placement of the UDI carrier on the label, aligned with the EUDAMED registration.
Learn more →Multilingual Labeling & Translation Management
Translation into the required EU official languages with translation memory and native-speaker technical review; the result is a terminologically consistent language version matrix per market.
eIFU Strategy per EU 2021/2226
Eligibility assessment of the electronic instructions for use per Regulation (EU) 2021/2226, risk assessment and a concept for the eIFU portal including proof of availability.
Link to the Technical Documentation
Traceability of every labeling statement to the risk analysis per ISO 14971:2019, the GSPR checklist and the usability file per IEC 62366-1.
Learn more →How we work together
What it comes down to
Labeling and the IFU look like a formality, but they are the point where the entire technical documentation becomes visible. Whatever appears on the label must be verifiable backwards: a warning points to a measure from the risk analysis per ISO 14971:2019, a symbol to the harmonized version of ISO 15223-1, a mandatory particular to the matching point in MDR (EU) 2017/745 Annex I Section 23 or IVDR (EU) 2017/746 Annex I Section 20. If the label is treated instead as a mere graphic artifact, contradictions arise that come back as findings in the conformity assessment procedure.
The sequence matters here too. Only once the intended purpose, the user group and the risk analysis are settled can the label be finalized. Only after that does the multilingual translation pay off, because otherwise every later content change has to be carried through all language versions. An IFU written only at the end of the project is, in case of doubt, translated twice; labeling coupled early to the technical documentation, only once.
Our approach
Our approach
Step
Result
Inventory
Complete list of existing labels, IFUs and language versions per device and market.
Compliance Review
Gap analysis against MDR Annex I Section 23 or IVDR Annex I Section 20 and ISO 15223-1, prioritized by audit relevance.
Development & Symbology
Release-ready label and IFU drafts with a standard-compliant symbol legend and UDI carrier.
Translation & Review
Multilingual language versions with native-speaker technical review and consistent terminology.
Linking & Release
Labeling dossier with traceability to the risk analysis and the GSPR checklist, released for the technical documentation.
Common pitfalls
Where projects commonly fail
The label is designed in isolation from risk management.
Warnings and residual risks on the label and IFU must match the risk analysis per ISO 14971:2019; if the wording deviates, a contradiction arises in the technical documentation that the notified body will pick up.
Outdated or self-designed symbols instead of ISO 15223-1.
The current symbol version is often not updated, or proprietary pictograms are used. Both lead to objections, because the symbology does not conform to the harmonized standard.
Multilingual IFUs are allowed to drift apart in content.
If a change is maintained only in the source language, divergent language versions arise; without translation memory and version control, the German IFU then ends up more current than the translated one.
An eIFU is introduced without checking eligibility.
Regulation (EU) 2021/2226 permits electronic instructions for use only for certain devices and user groups; for lay-user devices the paper IFU remains mandatory unless an exemption applies.
The UDI particular is missing from the label or is not aligned with the EUDAMED registration.
A missing or inconsistent UDI carrier is a classic finding, because the label and the database must bear the same identifier.
FAQ
Frequently asked questions
Sources
- Regulation (EU) 2017/745 (MDR) - primary text, Annex I Chapter III, Section 23
- Regulation (EU) 2017/746 (IVDR) - primary text, Annex I Section 20
- Regulation (EU) 2021/2226 on electronic instructions for use for medical devices (replaces Regulation (EU) 207/2012)
- ISO 15223-1 - symbols to be used with medical device labels
- EN ISO 20417 - information to be supplied by the manufacturer
- ISO 14971:2019 - application of risk management to medical devices
- https://theentourage.de/regulatory-compliance/labeling-ifu-erstellung/ (existing page content, revised)
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Case Studies
What this looks like in practice
Related insights
All insights →Regulations & standards considered
- EU 2017/745 (MDR) Annex I Section 23 (label and instructions for use)
- EU 2017/745 (MDR) Annex I Chapter III (requirements regarding the information supplied with the device)
- EU 2017/746 (IVDR) Annex I Section 20 (label and instructions for use)
- Regulation (EU) 2021/2226 (electronic instructions for use, eIFU, replaces 207/2012 for MDR devices)
- ISO 15223-1 (symbols to be used with medical device labels)
- EN ISO 20417 (information to be supplied by the manufacturer)
- IEC 62366-1 (application of usability engineering)
- ISO 14971:2019 (risk management for medical devices)
Related topics
Technical Writing →
Technical documentation into which labeling and the IFU feed traceably
MDR Consulting →
Labeling as part of the conformity assessment per EU 2017/745
IVDR Readiness →
Labeling requirements for in-vitro diagnostics per EU 2017/746
EUDAMED →
UDI on the label, aligned with the EUDAMED registration
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