E-label vs physical label: rules by jurisdiction
Cross-cutting regulatory labelling guide
The shift from a printed regulatory marking to an electronic label, designated in the literature as e-label, accompanies the miniaturisation of connected products. For a BLE sensor the size of a coin, an IoT industrial module a few millimetres thick, or an IP camera intended for an outdoor pole, the surface available to carry an FCC ID, an IC identifier, a CE marking, a GITEKI symbol and a KC mark becomes a mechanical constraint on the same order as antenna placement or thermal dissipation. The e-label, defined as the display of regulatory information through an integral screen or a documented access procedure, is however not universally recognised. Each authority has its own framework, its own content requirements, and its own threshold of acceptability. This page documents the state of the rules jurisdiction by jurisdiction as of spring 2026, the content required when the label is electronic, the access mechanisms accepted, and the pitfalls that cause a certification to fail solely on the labelling dimension.
Why an e-label
Section titled “Why an e-label”Three independent forces push toward the electronic label.
The first is physical congestion. A product certified for the United States, Canada, the European Union, the United Kingdom, Australia, Japan and Korea typically carries between five and nine distinct regulatory markings. On a 20 mm by 30 mm enclosure, the surface no longer allows each to be rendered legibly and indelibly.
The second is regulatory agility. A product whose list of authorised countries evolves over time (band addition, certification deferred for a tertiary market) tolerates poorly an engraved or silkscreened marking that has to be requalified at every revision. A software menu is amended by firmware update.
The third is durability. A printed physical label fades, in particular on wearables exposed to sweat, household solvents or washing. An electronic label stored in flash is readable as long as the product functions.
These motivations explain why the e-label was first adopted in the United States, where the density of markings is highest and where the smartphone industry pushed the topic to the FCC starting in 2013.
The E-LABEL Act and 47 CFR 2.935
Section titled “The E-LABEL Act and 47 CFR 2.935”The US framework rests on the combination of a federal statute and an implementing rule.
The statute, titled Enhance Labeling, Accessing, and Branding of Electronic Licenses Act, was enacted by Congress in November 2014 (Public Law 113-197). It authorises the FCC, without mandating it, to recognise electronic labels for devices with an integral display. The FCC transposed the mandate into a rule published at 47 CFR 2.935.
The rule sets out the substantive conditions.
| FCC requirement | Practical disposition |
|---|---|
| Integral display capability | The device has a screen capable of presenting the FCC ID in clear readable form |
| Access without third-party application | The information is accessible natively, without download |
| Three steps maximum | The user reaches the compliance information screen in three manipulations or fewer from the main menu |
| Permanent access | The information remains accessible throughout the product's life, including after battery depletion and recharge |
| Not user-modifiable | The end user cannot erase or modify the content |
| Required content | FCC ID, complementary regulatory identifiers, Part 15 or other statements required by the applicable rule |
| Access instructions | Provided on the product, on the packaging, or in the accompanying documentation |
The rule leaves the manufacturer free to choose the access mechanism (menu, key sequence, scan of a physical QR code pointing to a URL hosted by the manufacturer) so long as the cumulative conditions are met.
See the FCC pillar for the broader US framework.
EU regulation: CE must remain physical
Section titled “EU regulation: CE must remain physical”The contrast with the European Union is sharp. The CE marking is governed by Regulation (EC) 765/2008 and by the applicable product directives (RED for radio equipment, EMC, LVD, Machinery, MDR, IVDR depending on scope). None of these standards currently recognises, as a general rule, a purely electronic CE marking in lieu of the physical label.
The CE marking must be affixed visibly, legibly and indelibly on the product. Where the nature of the product does not permit this, the marking is placed on the packaging and on the accompanying documents. The derogation is used for small items, but it does not move the marking onto a screen.
The RED (Directive 2014/53/EU) further requires that the CE marking be accompanied by the notified body number where such a body has intervened, on the product or failing that on the packaging and the manual.
A change is under discussion within the revision of the New Legislative Framework and in sectoral proposals, but no legislative act adopted as of spring 2026 generalises the CE e-label. The prudent design stance is to plan for a physical CE label and not to base an EU market entry strategy on the assumption of imminent recognition of the CE e-label.
The EU does provide a neighbouring but distinct framework: electronic instructions for use (eIFU). Reserved to medical devices and governed by Commission Implementing Regulation (EU) 2021/2226, this framework authorises the electronic provision of instructions for use, under conditions, for devices intended for healthcare professionals. It does not concern the regulatory label itself and does not extend to consumer products.
For CE marking and its dimensions, see the CE pillar.
United Kingdom: UKCA aligned with the EU
Section titled “United Kingdom: UKCA aligned with the EU”The UKCA marking, which replaces the CE marking for placing on the market in Great Britain (England, Wales, Scotland) since the end of the post-Brexit transition period, follows the same principles as the CE marking in terms of physical affixing. The UK Statutory Instruments transposed from EU directives preserve the visible, legible and indelible label rule.
Northern Ireland remains under EU regime for products placed on its market, which keeps the physical CE marking with a complementary UKNI in some cases. No UK provision in 2026 recognises an e-UKCA. See UKCA marking for the details.
Canada: ISED RSS-Gen e-label section
Section titled “Canada: ISED RSS-Gen e-label section”ISED accepts the electronic label under conditions explicitly listed in RSS-Gen (section dedicated to electronic labelling). The requirements are close to the FCC's, with two notable differences.
First difference: a secondary physical label must be placed on the product or on the accompanying documentation, indicating the access procedure to the IC information. The FCC accepts that this instruction be given only in the documentation; ISED requires a physical reference on the product or accompanying documentation.
Second difference: the IC identifier must appear on the packaging of the product in plain text, independently of the e-label. This dual requirement (e-label on the screen plus IC on packaging) reflects Canadian customs practice, where border verification is performed without being able to power up the product.
See ISED Canada for the general context.
Australia: ACMA and the RCM marking
Section titled “Australia: ACMA and the RCM marking”The ACMA authorises the electronic display of the RCM marking for products with an integral display, under the Radiocommunications Devices (Compliance Labelling) Notice. The requirements are:
- The screen must be integral to the product and accessible without disassembly.
- The RCM marking must be displayed in a screen identified as such.
- The access procedure must be documented in the supplier's Compliance Folder.
- The access instruction must be available to the end user.
The Australian rule is distinctive in its requirement to maintain a Compliance Folder, a dossier the supplier must be able to produce on ACMA demand for five years after the last placing on the market. Evidence of the e-label implementation (screen capture, user manual, photo of the access instruction) is part of it.
Japan: MIC and GITEKI
Section titled “Japan: MIC and GITEKI”In Japan, the MIC (Ministry of Internal Affairs and Communications) recognises the electronic display of the GITEKI mark (Japanese radio conformity marking) for products with an integral display. The framework rests on the Radio Law and on MIC Notifications that specify the conditions of electronic presentation.
The Japanese conditions are:
- The display must include the recognisable GITEKI graphic symbol, plus the certification number.
- Access is through the integral menu, without network dependency.
- A secondary physical label pointing to the menu is required.
- For products without a display, the physical marking remains mandatory with no derogation.
The Japanese specificity is the requirement of the GITEKI graphic symbol, which must be rendered recognisably on the screen and cannot be replaced by an equivalent text.
Korea: electronic KC mark
Section titled “Korea: electronic KC mark”The KCC (Korea Communications Commission) and the RRA (Radio Research Agency) accept an electronic presentation of the KC mark for certain categories of radio equipment, under conditions set out in RRA Notices. The framework is more restrictive than in the United States: it applies primarily to smartphones, tablets and equipment with a rich display, and does not extend to all radio products. A physical label remains required for categories not covered.
See KC South Korea for the general KC framework.
China: CCC remains physical
Section titled “China: CCC remains physical”The CNCA (Certification and Accreditation Administration) has not, as of spring 2026, generalised acceptance of the e-label for the CCC marking (China Compulsory Certification). Products subject to CCC must carry the physical CCC marking on the product, in accordance with the Implementation Rules published by the CNCA for each category.
Sectoral experiments exist for some specific categories, but the general rule at the time of writing remains the physical CCC label. Any product strategy targeting the Chinese market must therefore plan for the CCC marking to be printed, engraved or silkscreened on the product. See CCC China.
MDR and eIFU: a framework distinct from the e-label
Section titled “MDR and eIFU: a framework distinct from the e-label”Commission Implementing Regulation (EU) 2021/2226 governs, for medical devices and in vitro diagnostic medical devices, the possibility of providing instructions for use in electronic form (eIFU). The framework is restrictive:
- Reserved to devices intended exclusively for healthcare professionals (with a few exceptions for active implantable devices under specific conditions).
- The manufacturer must provide, on user request, a free paper version within a reasonable timeframe.
- The electronic information must be accessible via a stable website, multilingual according to the target market requirements, with guaranteed availability and a continuity plan.
- The benefit/risk assessment of the eIFU must be documented in the device technical file.
The eIFU framework is not an e-label: it concerns the instructions for use, not the device's regulatory marking. The physical CE marking remains required on the medical device, in accordance with Article 20 of the MDR (Regulation (EU) 2017/745) and with the IVDR.
Jurisdiction summary
Section titled “Jurisdiction summary”| Jurisdiction | E-label | Secondary physical marking | Mention on packaging | Regulatory basis |
|---|---|---|---|---|
| US (FCC) | Accepted under conditions | Not required | Recommended | 47 CFR 2.935, E-LABEL Act 2014 |
| EU (CE/RED) | Not accepted as a general rule | Physical CE marking required | If small-item derogation | Reg (EC) 765/2008, RED 2014/53/EU |
| UK (UKCA) | Not accepted as a general rule | Physical UKCA marking required | If small-item derogation | UK Statutory Instruments post-Brexit |
| Canada (ISED) | Accepted under conditions | Required (access procedure) | Required (IC in plain text) | RSS-Gen e-label section |
| Australia (ACMA) | Accepted under conditions | Required (access procedure) | Per Notice | Radiocommunications Devices Notice |
| Japan (MIC) | Accepted under conditions | Required (menu pointer) | Per MIC notification | Radio Law + MIC Notices |
| Korea (KC) | Accepted for limited categories | Per RRA Notice | Per RRA Notice | RRA Notices |
| China (CCC) | Not generalised | Physical CCC marking required | Per Implementation Rules | CNCA Implementation Rules |
| MDR/IVDR (medical) | No (e-label) / eIFU for IFU | Physical CE marking required | Per directive | Reg (EU) 2017/745, Impl Reg 2021/2226 |
Required content on an e-label
Section titled “Required content on an e-label”The content required varies by jurisdiction, but converges on a set of information that must be presented on the compliance information screen.
| Item | FCC | ISED | ACMA | MIC | Comment |
|---|---|---|---|---|---|
| Primary identifier (FCC ID, IC, RCM, GITEKI) | Yes | Yes | Yes | Yes | Certification number must be readable in plain text |
| Manufacturer name | Yes | Yes | Yes | Per notification | Legal name or registered trademark |
| Product model | Yes | Yes | Yes | Yes | Commercial reference identical to the certification record |
| Part 15 or equivalent statement | Yes (Part 15 or 47 CFR 15.19) | Yes (licence-exempt RSS) | Per Notice | Per Radio Law | Exact text prescribed by the applicable rule |
| Bilingual statement (FR + EN) in Canada | No | Yes | No | No | RSS-Gen mandates the FR + EN statement |
| Radio safety warnings | Per product | Per product | Per Notice | Per notification | External antennas, RF exposure, conditions of use |
| Serial number or batch | Recommended | Recommended | Per Notice | Per notification | Not always mandatory but a best practice |
The absence of any of these elements where required is grounds for blocking certification. Market surveillance services verify the actual content on screen, and an FCC ID present but accompanied by a missing Part 15 statement is treated as non-conformity.
Access mechanisms
Section titled “Access mechanisms”Three access mechanisms are commonly used.
Hierarchical menu
Section titled “Hierarchical menu”The compliance information is presented in a menu of the user interface, accessible from the home screen. The typical path is: home screen, settings, about, regulatory information.
The FCC's three steps or fewer rule applies. The count is from the home screen. A menu buried behind an administrative parameter or a prior pairing procedure does not satisfy the rule.
For devices without a touch interface (BLE badge, miniature sensor with a single 0.5-inch OLED screen), the sequence is a documented combination of button presses described in the manual. The access procedure is considered user-accessible if it requires neither tool nor disassembly nor administrator authorisation.
Printed physical QR code
Section titled “Printed physical QR code”A QR code printed on the enclosure points to a URL hosted by the manufacturer and presenting the compliance information. This mechanism is not recognised as an e-label in the jurisdictions studied: it replaces neither the physical label nor the on-screen display. It does work, however, as a support for the access instruction to the menu-based e-label, in place of a text printed on the enclosure.
For a QR code to play this instruction role:
- The pointed URL must be stable and hosted by the manufacturer.
- The URL must remain active throughout the expected service life of the product (typically ten years for an industrial IoT product).
- The content accessible through the link must comply with the jurisdiction's requirements, including local language where required.
- The URL must not depend on a third-party service liable to shut down.
Online registry
Section titled “Online registry”For products without an integral display and intended for a market accepting remote access (rare), an online registry searchable by serial number is theoretically possible. No jurisdiction studied currently recognises it as replacing the physical label. The online registry is best conceived as a traceability complement, not as a compliant e-label.
Decision tree: physical or electronic label
Section titled “Decision tree: physical or electronic label”For a product in scoping phase:
- Does the product have an integral display capable of presenting readable textual information? If not, the physical label is mandatory in all jurisdictions studied. The e-label scoping stops here.
- Which markets are targeted? Establish the list of jurisdictions and identify those that accept the e-label (US, Canada, Australia, Japan, Korea in certain categories) and those that require the physical marking (EU, UK, China, plus the MDR/IVDR medical chain with no e-label exception).
- For the jurisdictions that accept the e-label, is the implementation effort justified? Design a compliance information menu, document the access procedure, retain evidence, translate the content. The effort pays off for products with high marking density and severe space constraints (wearables, miniature industrial modules).
- For the jurisdictions that require the physical marking, how should markings be placed? Single multi-jurisdiction label, detachable label on packaging for small items, laser engraving, indelible silkscreen. See the CE pillar for CE dimension rules.
- Document the coexistence of both approaches in the technical file. A single product can present an FCC ID as e-label and a CE marking as physical. The technical file must describe each of the two approaches and the associated evidence.
Common pitfalls
Section titled “Common pitfalls”Assuming the EU permits an electronic CE marking
Section titled “Assuming the EU permits an electronic CE marking”This is the most common pitfall, particularly on miniature wearables. No provision adopted as of spring 2026 generalises acceptance of a purely electronic CE marking. The small-item derogation of Regulation 765/2008 moves the marking to the packaging and the manual, not to a screen. Designing a product for the EU market on the assumption of an accepted e-CE is a scoping mistake that triggers a late mechanical redesign.
Omitting the secondary physical label in Canada
Section titled “Omitting the secondary physical label in Canada”ISED requires a secondary physical label bearing the access instruction to the e-label. A design inspired by the FCC model, which puts the instruction only in the manual, is non-compliant with RSS-Gen. Late correction forces a redesign of the physical label or a request for ISED guidance, typically delaying the project by two to four weeks.
Compliance screen accessible only after pairing
Section titled “Compliance screen accessible only after pairing”The three-steps-or-fewer requirement is assessed from the home screen in the product's normal operating state. A product that only displays its compliance menu after pairing with a smartphone, initial WiFi configuration or user authentication is non-compliant. The menu must be accessible from first boot, offline.
QR code pointing to a non-durable URL
Section titled “QR code pointing to a non-durable URL”A QR code printed on the enclosure pointing to a URL hosted by a third-party service (subcontractor cloud, external redirection service) creates a long-term failure risk. The URL must be owned by the manufacturer and included in its long-term maintenance plan. A certification resting on an external URL loses its operational validity if the URL becomes unreachable, even if the dossier remains formally valid.
Confusing MDR eIFU and product e-label
Section titled “Confusing MDR eIFU and product e-label”The eIFU under Commission Implementing Regulation (EU) 2021/2226 concerns the instructions for use of medical devices, not the CE marking of the device. A manufacturer invoking eIFU to exempt itself from the physical CE marking commits a legal error. The CE marking remains physical on the medical device, and the eIFU is added for the instructions for use.
User-modifiable compliance information
Section titled “User-modifiable compliance information”47 CFR 2.935 and RSS-Gen require that the information presented be non-modifiable by the end user. A settings page where the user can edit a "device name" field displaying the FCC ID is non-compliant. The content must be read-only and stored in a zone not accessible to the user.
Bilingual statement forgotten in Canada
Section titled “Bilingual statement forgotten in Canada”RSS-Gen mandates a bilingual French and English statement for warnings displayed in the compliance menu in Canada. An implementation aligned on the FCC e-label, in English only, is non-compliant. The translation must be integrated into the firmware before ISED submission.
Glossary and resources
Section titled “Glossary and resources”For the terms (FCC ID, IC, RCM, GITEKI, KC, CCC, eIFU, e-label), see the glossary. For the general US framework see the FCC pillar and for the European framework see the CE pillar. For Canadian certification, see ISED Canada. For the UKCA context, see UKCA marking.
See also
Section titled “See also”- Component substitution: when does a swap trigger retest?
- Change management: FCC Class II permissive and RED delta
- EU market surveillance and Safety Gate (formerly RAPEX)
- Product recall and EU Safety Gate response procedure
Sources & references
- E-LABEL Act of 2014 (Public Law 113-197) , US Congress www.congress.gov/bill/113th-congress/house-bill/5161
- 47 CFR 2.935: Electronic labeling of equipment , US Code of Federal Regulations www.ecfr.gov/current/title-47/chapter-I/subchapter-A/part-2/section-2.935
- ISED RSS-Gen: General Requirements for Compliance of Radio Apparatus , ISED Canada ised-isde.canada.ca/site/spectrum-management-telecommunications/en/spectrum-allocation/rss-gen-general-requirements-compliance-radio-apparatus
- Commission Implementing Regulation (EU) 2021/2226 on electronic instructions for use of medical devices , European Union eur-lex.europa.eu/eli/reg_impl/2021/2226/oj
- Regulation (EC) 765/2008: Accreditation and market surveillance, CE marking rules , European Union eur-lex.europa.eu/eli/reg/2008/765/oj
- ACMA Radiocommunications Devices (Compliance Labelling) Notice , ACMA Australia www.acma.gov.au/labelling-requirements-suppliers