ISO 15223-1 Medical Device Symbols: Complete Labeling and Marking Guide (2026)
Guide to ISO 15223-1 medical device symbols and labeling, covering the 2025 EU REP amendment, MDR/IVDR requirements, symbol validation, categories, and implementation.
What Is ISO 15223-1?
ISO 15223-1 specifies the symbols used to express information supplied by the manufacturer of medical devices. These symbols can appear on the device itself, on its packaging, or in accompanying information such as Instructions for Use (IFU). The standard provides a globally recognized graphical language that eliminates the need for multilingual text on medical device labels — critical for manufacturers marketing products across countries with different language requirements.
The current active version is ISO 15223-1:2021 (fourth edition), which was harmonized under the EU MDR and EU IVDR in January 2022 — one of relatively few standards to achieve harmonized status. An important update, ISO 15223-1:2021/Amd 1:2025 (Amendment 1), was published in late 2025 and introduces changes to the authorized representative symbol (EC REP to EU-REP) and adds new defined terms.
Compliance with EN ISO 15223-1 provides presumption of conformity with the General Safety and Performance Requirements (GSPRs) of both EU MDR Article 2 and EU IVDR Annex I, Chapter III, for labeling requirements. This is one of the strongest regulatory incentives for using the standard's symbols.
Why ISO 15223-1 Matters for Medical Device Manufacturers
Medical device labeling is a regulatory requirement in every major market. The EU MDR Annex I, Section 23.2 specifies dozens of pieces of information that must appear on device labels. Using ISO 15223-1 symbols instead of text in multiple languages offers several advantages:
Space efficiency — Symbols take far less space than multilingual text, critical for small devices and packaging
Cost reduction — Avoid the expense of printing labels in 24+ EU official languages
Regulatory compliance — Harmonized status provides presumption of conformity with MDR/IVDR GSPRs
Global consistency — A single set of symbols understood across all markets
Risk mitigation — Properly validated symbols reduce the risk of misinterpretation
Regulatory Framework
| Regulation / Standard | Relationship to ISO 15223-1 |
|---|---|
| EU MDR 2017/745 (Annex I, Chapter III) | Specifies labeling information requirements; ISO 15223-1 symbols satisfy these requirements |
| EU IVDR 2017/746 (Annex I, Chapter III) | Same as MDR for IVD devices |
| ISO 20417:2026 | Specifies what information must be supplied by the manufacturer; ISO 15223-1 specifies how to present it using symbols. FDA Rec# 5-149; DoC to the 2021 edition (Rec# 5-135) accepted until July 1, 2029. |
| ISO 15223-2 | Specifies the validation methodology for new symbols before they can be used |
| FDA 21 CFR Part 801 | US labeling requirements; FDA recognizes ISO 15223-1 symbols |
| MDCG guidance documents | Provide additional interpretation of labeling requirements under MDR |
Amendment 1:2025 — The EU-REP Symbol Change
The most significant recent change to ISO 15223-1 is Amendment 1:2025, which addresses a specific problem: the existing "EC REP" symbol for the European Authorized Representative could be confused with Ecuador (ISO 3166 Alpha-2 country code "EC"). At the European Commission's request, ISO developed this amendment.
What Changed
EC REP symbol renamed to EU-REP — The symbol's defined term changes from "Authorized Representative in the European Community/European Union" to "Authorized Representative" with a region-neutral designation
Modified symbol graphic — The symbol no longer includes a country or region-specific identifier, making it more universally applicable
New defined term — "Authorized representative" is now formally defined in the standard, aligned with MDR Article 2(35) definition
This amendment affects every manufacturer that uses an Authorized Representative in Europe — which includes all non-EU manufacturers placing devices on the EU market. Updated labels should transition to the new EU-REP symbol.
Timeline for Implementation
The amendment was published in late 2025, with national implementations (such as SIST EN ISO 15223-1:2021/A1:2026) taking effect in early 2026. Manufacturers should begin transitioning to the new symbol in new label designs. For existing inventory, coordinate with your Notified Body on acceptable transition periods.
Complete Symbol Reference by Category
ISO 15223-1:2021 organizes symbols into categories based on the type of information they convey. The fourth edition added 25 new symbols compared to the third edition (ISO 15223-1:2016), including 20 that were validated per ISO 15223-2 and 5 from existing ISO 7000, ISO 7001, and IEC 60417 registrations.
Category 5.1: Manufacturer Information
| Ref | Symbol Title | Description | Key Requirements |
|---|---|---|---|
| 5.1.1 | Manufacturer | Identifies the medical device manufacturer | Must appear with name and address adjacent to the symbol |
| 5.1.2 | Authorized Representative | Identifies the EU Authorized Representative | Must appear with name and address; updated per Amd 1:2025 |
| 5.1.3 | Date of manufacture | Indicates when the device was manufactured | Date format: YYYY-MM-DD or as specified |
| 5.1.4 | Importer | Identifies the importer per MDR Article 2(38) | New in 4th edition; name and address required |
Category 5.2: Sterilization and Packaging
| Ref | Symbol Title | Description | Key Requirements |
|---|---|---|---|
| 5.2.1 | Sterilized using irradiation | Device sterilized by gamma, e-beam, or X-ray | Specify method if needed |
| 5.2.2 | Sterilized using ethylene oxide | Device sterilized by EtO | — |
| 5.2.3 | Sterilized using steam or dry heat | Device sterilized by autoclave | — |
| 5.2.4 | Sterilized using aseptic processing | Device manufactured using aseptic technique | Not a terminal sterilization method |
| 5.2.5 | Do not re-sterilize | Device must not be re-sterilized | — |
| 5.2.6 | Do not use if package is damaged | Integrity check required before use | — |
| 5.2.7 | Single sterile barrier system | One sterile barrier layer | New in 4th edition |
| 5.2.8 | Double sterile barrier system | Two sterile barrier layers | New in 4th edition |
| 5.2.9 | Sterile fluid path | Fluid path is sterile; exterior may not be | Identify the sterile portion in IFU |
| 5.2.10 | Sterilized using vaporized hydrogen peroxide | VH2O2 sterilization | New in 4th edition |
| 5.2.11 | Single sterile barrier system | Alternative symbol for single barrier | New in 4th edition |
| 5.2.12 | Double sterile barrier system | Alternative symbol for double barrier | New in 4th edition |
Category 5.3: Date and Lot Information
| Ref | Symbol Title | Description | Key Requirements |
|---|---|---|---|
| 5.1.3 | Date of manufacture | Manufacturing date | YYYY-MM-DD preferred |
| 5.1.5 | Use-by date | Expiration date beyond which device must not be used | Mandatory for sterile, single-use, and perishable devices |
| 5.1.6 | Batch/lot number | Manufacturing batch identification | Must be traceable to production records |
| 5.1.7 | Serial number | Unique device serial number | Required for tracking and recall purposes |
| 5.1.8 | Model/reference number | Catalog or article number | Links to product documentation |
Category 5.4: Safety and Regulatory Information
| Ref | Symbol Title | Description | Key Requirements |
|---|---|---|---|
| 5.4.1 | Do not re-use | Single-use device only | MDR Article 2(41) implications for reprocessing |
| 5.4.2 | Consult instructions for use | IFU must be consulted before use | Mandatory when IFU is provided separately |
| 5.4.3 | Caution | Consult IFU for important safety information | US FDA also recognizes this symbol |
| 5.4.4 | Prescription only (US) | Device available by prescription only | US market specific |
| 5.4.5 | Consult electronic instructions for use | IFU available electronically | Must provide URL or QR code |
| 5.4.6 | Contains or presence of phthalate | Device contains phthalates (e.g., DEHP) | Per EN 15986; specify chemical abbreviation |
| 5.4.7 | Contains human blood/plasma derivatives | Biological material of human origin | MDR Annex I, 23.2(e) |
| 5.4.8 | Contains medicinal substance | Drug-device combination | MDR Annex I, 23.2(e) |
| 5.4.9 | Contains hazardous substances | CMR or endocrine-disrupting substances | MDR Annex I, 23.2(f) |
| 5.4.10 | Contains biological material of animal origin | Animal-derived materials | MDR Annex I, 23.2(e) |
| 5.4.11 | Contains nanomaterials | Device contains engineered nanomaterials | MDR increased focus on nanomaterials |
| 5.4.12 | Single patient multiple use | May be used on one patient across procedures | New in 4th edition |
Category 5.5: IVD-Specific Symbols
| Ref | Symbol Title | Description | Key Requirements |
|---|---|---|---|
| 5.5.1 | In vitro diagnostic medical device | Identifies IVD device | EU IVDR definition applies |
| 5.5.2 | Positive control | Positive control material included | IVD performance verification |
| 5.5.3 | Negative control | Negative control material included | IVD performance verification |
Category 5.6: UDI and Identification
| Ref | Symbol Title | Description | Key Requirements |
|---|---|---|---|
| 5.7.7 | Medical Device | Indicates the item is a medical device | MDR Annex I, 23.2(q) |
| 5.7.10 | Unique Device Identifier | UDI carrier containing UDI data | MDR Article 27; AIDC and HRI required |
Category 5.7: Transport and Storage
| Ref | Symbol Title | Description | Key Requirements |
|---|---|---|---|
| 5.3.1 | Temperature limits | Upper and lower temperature limits | Must specify range |
| 5.3.2 | Humidity limitation | Maximum relative humidity | — |
| 5.3.3 | Atmospheric pressure limitation | Pressure constraints for transport/storage | — |
| 5.3.4 | Keep dry | Protect from moisture | — |
| 5.3.5 | Fragile, handle with care | Device is fragile | — |
| 5.3.6 | Keep away from sunlight | Protect from UV exposure | — |
| 5.3.7 | Do not use if package is damaged | Packaging integrity required | — |
| 5.3.8 | Orient upward | Keep in specified orientation | — |
How to Use ISO 15223-1 Symbols Correctly
Risk-Based Approach to Symbol Selection
Before using symbols on your device labeling, conduct a risk assessment to determine whether it is appropriate to use a particular symbol. Key considerations:
User population — Trained healthcare professionals vs. lay users
Device complexity — Simple devices may need fewer symbols; complex devices may need more
Packaging constraints — Small devices and packaging may benefit most from symbol use
Regional requirements — Some markets require text explanations alongside symbols
When Symbols Must Be Explained
If the device is intended for lay users (patients, caregivers), symbols must always be explained in the accompanying documentation. Manufacturers cannot assume that laypersons will understand symbols without explanation. For professional users, symbols from ISO 15223-1 are generally understood without explanation, but manufacturers should still verify comprehension for less common symbols.
Symbol Validation per ISO 15223-2
New symbols proposed for inclusion in ISO 15223-1 must be validated in accordance with ISO 15223-2. The validation process ensures that the symbol is:
Comprehensible — The intended meaning is understood by the target user population
Unambiguous — The symbol does not have multiple conflicting interpretations
Distinguishable — The symbol is not easily confused with other existing symbols
Applicable — The symbol is relevant to a range of medical devices and has global or regional applicability
Symbols already registered under ISO 7000, ISO 7010, or IEC 60417 are exempt from this validation requirement.
Practical Label Design Considerations
| Consideration | Recommendation |
|---|---|
| Minimum symbol size | Ensure symbols are legible at the intended viewing distance; typically minimum 5mm for packaging symbols |
| Contrast | Symbols must have sufficient contrast against the background color |
| Placement | Symbols should be grouped logically and not obstructed by packaging seals or folds |
| Color | Black on white is standard; blue symbols are acceptable when consistent with brand guidelines |
| Orientation | Symbols should maintain their standard orientation unless packaging constraints require rotation |
| Adjacent text | Some symbols require accompanying text (manufacturer name/address, lot number, date) |
| QR codes | If using electronic IFU symbols, ensure QR codes are scannable and link to the correct content |
ISO 15223-1 and EU MDR Compliance
MDR Annex I, Chapter III Mapping
EN ISO 15223-1 includes annexes that map each symbol to the specific MDR/IVDR requirement it addresses. This mapping is critical for demonstrating compliance:
| MDR Annex I Requirement | ISO 15223-1 Symbol(s) |
|---|---|
| 23.2(a) — Device name/trade name | Text required (not symbolized) |
| 23.2(b) — Details to identify device | 5.1.8 (Model/reference), 5.1.6 (Batch), 5.1.7 (Serial) |
| 23.2(c) — Manufacturer name and address | 5.1.1 (Manufacturer) |
| 23.2(d) — Authorized representative | 5.1.2 (EU-REP per Amd 1:2025) |
| 23.2(e) — Contents, biological materials | 5.4.7-5.4.10 (various content symbols) |
| 23.2(f) — Hazardous substances | 5.4.9 (Hazardous substances) |
| 23.2(g) — Net quantity | Text required |
| 23.2(h) — Sterility status | 5.2.1-5.2.5 (Sterilization symbols) |
| 23.2(i) — Date of minimum durability | 5.1.5 (Use-by date) |
| 23.2(j) — Storage/handling conditions | 5.3.1-5.3.8 (Transport/storage symbols) |
| 23.2(k) — Lot/serial number | 5.1.6 (Batch), 5.1.7 (Serial) |
| 23.2(l) — UDI carrier | 5.7.10 (UDI) |
| 23.2(m) — Importer name and address | 5.1.4 (Importer) |
| 23.2(q) — "Medical Device" indication | 5.7.7 (Medical Device) |
Where to Obtain ISO 15223-1 Symbols
The symbols defined in ISO 15223-1 are drawn from the ISO 7000 database ("Graphical symbols for use on equipment"). Sources for obtaining compliant symbol artwork:
ISO website — The ISO Browsing Area (obp) provides symbol reference numbers and registration dates
MedTech Europe — Publishes free symbol files for most MDR-relevant symbols
Notified Body guidance — Some Notified Bodies provide symbol sets to their clients
Standards purchase — The full ISO 15223-1 standard document includes all symbol graphics
Symbols registered under ISO 7000 have unique reference numbers and registration dates, which are listed in the final column of the symbol tables in ISO 15223-1.
Comparison: ISO 15223-1:2016 vs. ISO 15223-1:2021
| Aspect | 3rd Edition (2016) | 4th Edition (2021) + Amd 1:2025 |
|---|---|---|
| Total symbols | ~25 core symbols | 50+ symbols (25 new in 4th edition) |
| Authorized rep symbol | EC REP | EU-REP (per Amendment 1:2025) |
| UDI symbol | Not included | Included (5.7.10) |
| Importer symbol | Not included | Included (5.1.4) |
| Medical Device symbol | Not included | Included (5.7.7) |
| Sterile barrier symbols | Limited | Single/double barrier symbols added |
| Nanomaterial symbol | Not included | Included (5.4.11) |
| IVD-specific symbols | Not included | Section 5.5 added |
| Electronic IFU symbol | Not included | Included (5.4.5) |
| MDR harmonization | Not harmonized under MDR | Harmonized January 2022 |
| Alignment with EU MDR/IVDR | Partial | Full alignment with MDR Annex I Chapter III |
| Symbol validation | ISO 15223-2 referenced | Same, plus 20 new symbols validated per ISO 15223-2 |
Implementation Checklist for Manufacturers
Audit current labels — Compare existing label artwork against ISO 15223-1:2021 requirements
Update EC REP to EU-REP — Implement the Amendment 1:2025 symbol change
Verify MDR Annex I mapping — Ensure all 23.2 requirements are addressed by symbols or text
Add new mandatory symbols — UDI carrier, Medical Device indication, Importer
Risk assess symbol usage — Document the rationale for using symbols vs. text for each label element
Validate for lay users — If the device is used by patients, ensure all symbols are explained in IFU
Obtain compliant artwork — Source symbol graphics from ISO, MedTech Europe, or other authoritative sources
Update label specifications — Revise label drawings and specifications in your DHF/TF
Coordinate with Notified Body — Discuss symbol changes during your next conformity assessment
Train labeling and RA teams — Ensure teams understand the new symbols and their correct application
FAQ
Is ISO 15223-1 mandatory for medical device manufacturers? ISO 15223-1 is a voluntary standard, but in the EU, EN ISO 15223-1 is harmonized under both the MDR and IVDR, meaning compliance provides presumption of conformity with the labeling GSPRs. The FDA also recognizes ISO 15223-1 symbols. If you sell medical devices in the EU or US, using these symbols is the standard industry practice and significantly simplifies regulatory compliance.
What changed with Amendment 1:2025? The key change is the EC REP symbol being replaced with EU-REP to avoid confusion with Ecuador's ISO 3166 country code. The amendment also adds a formal definition for "authorized representative" and makes the symbol region-neutral. This affects all non-EU manufacturers who use an Authorized Representative to place devices on the EU market.
Do I need to explain all symbols in the IFU? For devices used by lay persons (patients, non-professional caregivers), you must explain all symbols in the accompanying documentation. For professional users, the harmonized symbols in ISO 15223-1 are generally accepted without explanation. However, less common symbols should be explained regardless of user type.
What is the difference between ISO 15223-1 and ISO 20417? ISO 20417 specifies what information must be supplied by the manufacturer (content requirements), while ISO 15223-1 specifies how to present that information using symbols (format requirements). The current ISO edition is ISO 20417:2026; FDA recognized it as Rec# 5-149 on Recognition List Number 066, with Declarations of Conformity to the 2021 edition (Rec# 5-135) still accepted until July 1, 2029. See the operating manual: ISO 20417:2026 FDA Rec# 5-149 and the July 1 2029 DoC window. ISO 20417 replaced the older EN 1041 standard and is used alongside both EU MDR and EU IVDR information requirements. Together, ISO 20417 and ISO 15223-1 provide a complete framework for medical device labeling.
Can I create my own symbols? You can, but custom symbols must be validated per ISO 15223-2 to demonstrate that your target user population understands their meaning. This is a resource-intensive process. It is almost always preferable to use existing ISO 15223-1 symbols or symbols from ISO 7000/IEC 60417, which are already validated and recognized.
How does the UDI symbol relate to ISO 15223-1? Symbol 5.7.10 in ISO 15223-1 represents the UDI carrier. Under MDR Article 27 and Annex VI, the UDI carrier must include both the Automatic Identification and Data Capture (AIDC) element (e.g., barcode) and the Human Readable Interpretation (HRI). The UDI symbol indicates where the UDI carrier is located on the label or device.
What if my packaging is too small for all required symbols? The MDR provides some flexibility for small devices and packaging. You may use fold-out labels, peel-off labels, or cross-reference to the IFU for detailed information. However, certain critical symbols (manufacturer, use-by date, lot number, UDI, and sterilization status for sterile devices) must appear on the immediate container. Document your labeling constraints and rationale in your technical file.
Does ISO 15223-1 apply to IVD devices? Yes. EN ISO 15223-1 is harmonized under both the MDR and IVDR. Section 5.5 of the standard includes IVD-specific symbols such as the in vitro diagnostic medical device symbol, positive control, and negative control. IVD manufacturers should use the same framework as other medical device manufacturers for symbol-based labeling.