Labeling Medical Devices

This topic is part of the SG Systems Global regulatory & operations glossary.

Updated October 2025 • Device Labeling & UDI • QA, RA, Clinical, Packaging, Manufacturing, IT

Labeling medical devices means far more than printing a sticker. It covers every piece of information that accompanies the device and shapes how it is selected, installed, used, maintained, reprocessed, and disposed of: physical labels, packaging, instructions for use (IFU/eIFU), web portals, app screens, and safety communications. Regulators treat labeling as a direct control on patient risk—if the labeling is wrong, unclear, incomplete, or out of date, the device is effectively misbranded, even if the hardware works perfectly.

“If users can’t understand exactly what the device is, what it does, and how to use it safely from the labeling, you don’t have a labeling problem—you have a patient safety problem.”

1) What Counts as “Labeling” for a Medical Device?

Regulators use “labeling” broadly. It typically includes:

• Device labels: information printed or affixed directly to the device (name, model, serial/lot, UDI, key warnings).
• Packaging labels: primary and secondary packaging with identification, storage conditions, sterilization status, and handling instructions.
• Instructions for Use (IFU) / eIFU: printed or electronic user manuals, quick-start guides, and operator reference cards.
• Digital content: app screens, web portals, dashboards, and software dialogs for SaMD and connected devices.
• Accompanying information: training materials, safety leaflets, and field safety notices when they are required to use the device safely.

Marketing brochures and websites can also be treated as labeling if they make claims that influence how the device is used or understood.

2) Regulatory Anchors for Device Labeling

Labeling requirements for medical devices and IVDs derive from multiple sources:

• Regional regulations (e.g. EU MDR/IVDR, US FDA, UKCA, other national laws).
• QMS standards such as ISO 13485 (design and control of labeling processes).
• Risk management expectations (ISO 14971) linking labeling content to risk controls.
• Symbol and information standards (e.g. ISO 15223-1 for symbols, ISO 20417 for information supplied by the manufacturer).

Your labeling system must sit inside the QMS with clear interfaces to design control, risk files, vigilance, and change control—otherwise you end up with labels drifting away from the approved device and dossier.

3) Core Elements of Medical Device Labeling

At minimum, device labeling typically needs to make the following obvious:

• Who: name and address of manufacturer (and authorized representative/importer where required).
• What: device name, model, and clear description of the function.
• Which unit: lot or serial number, and UDI where applicable.
• Where and how used: intended purpose, patient population, and use environment.
• Warnings and contraindications: critical risks that must be understood before use.
• Storage and handling: conditions (temperature, humidity, protection from light, etc.).
• Sterility and single-use status: sterile/non-sterile, method of sterilization, and reuse/reprocessing limits.

The IFU builds on this with detailed instructions, troubleshooting, maintenance, and, where applicable, reprocessing instructions for reusable devices.

4) Intended Purpose, Indications & Claims

Labeling is the primary way the manufacturer communicates the intended purpose of the device. It must:

• Match the indications, claims, and limitations defined in the technical documentation and regulatory submissions.
• Clearly describe who the device is for (patient group), what it is used for, and under what conditions.
• Avoid off-label suggestions, implied claims, or ambiguous language that opens the door to misuse.
• Align with clinical evaluation / performance evaluation conclusions and risk files.

If the label promises more than the supporting data and risk analysis can justify, you’re carrying hidden regulatory and liability risk, regardless of how polished the artwork is.

5) Symbols, Languages & Readability

Modern device labels rely heavily on standardized symbols and multilingual information. Robust labeling practice includes:

• Using harmonized symbols (e.g. ISO 15223-1) to convey common concepts—sterile, single use, manufacturer, UDI carrier, lot, serial, “consult IFU”.
• Providing translations into required languages for each market, with controlled translation and review processes.
• Designing for legibility: font size, contrast, layout, and avoidance of clutter.
• Ensuring critical safety information is not reduced to tiny footnotes or dependent solely on color coding.

Regulators and human-factors reviewers increasingly expect evidence (e.g. usability studies) that users can find, understand, and act on key labeling information under realistic conditions.

6) UDI, Traceability & DHR/eDHR

Labeling is a front-line traceability mechanism. For many devices, labels must carry:

• UDI-DI and UDI-PI: human-readable and machine-readable identifiers linking to registration databases and internal systems.
• Lot or serial number: enabling reconstruction of the complete DHR or eDHR.
• Manufacturing date / expiry date: where shelf-life, sterility, or performance depends on time.

Internally, labels must match the device records in ERP/MES/QMS; mismatched UDI or lot codes between the label and the electronic device history is a common, high-risk audit finding.

7) Sterile, Single-Use, Reusable & Reprocessing Information

For invasive, implantable, sterile, or reusable devices, labeling must clearly communicate:

• Sterility status, sterilization method, and sterile barriers.
• Whether the device is single-use only or reusable, using clear text and symbols.
• Validated cleaning, disinfection, and sterilization procedures for reusable devices.
• Maximum cycles or reprocessing limits, and criteria for inspection and discard.

These details must be supported by validation data and risk analysis—if reprocessing instructions are vague or unvalidated, you can expect scrutiny from auditors and potentially safety alerts in the field.

8) Software, Connectivity & Electronic Labeling (eIFU)

For software-based and connected devices, labeling extends into the digital experience:

• On-screen instructions, warnings, and prompts used during setup, calibration, or operation.
• In-app help, tooltips, and online manuals (eIFU) when allowed by regulation.
• Version-specific information (software versions, cybersecurity updates, compatibility matrices).
• Connectivity and data use statements, including how the device interacts with other systems.

Software updates that change behavior, indications, or cybersecurity posture often require labeling updates, which must be controlled under the same QMS rules as printed labels and IFUs.

9) Labeling Change Control & Version Management

Labeling must be managed under strict change control. A robust process:

• Links every labeling change to a documented rationale (risk, PMS data, regulatory change, new market, or product enhancement).
• Assesses impact on risk management, clinical evaluation, regulatory submissions, and manufacturing.
• Ensures controlled roll-out: new labels on new builds, handling of existing stock, and clear cut-over points.
• Captures versions in the DHR/eDHR so you know exactly which labeling set went with each batch or serial.

“Quiet” labeling tweaks without risk or regulatory assessment are a classic root cause of misbranding findings and recall situations.

10) PMS, Complaints, Vigilance & Label Changes

Labeling is both an input and output of post-market surveillance (PMS) and vigilance:

• Complaints and adverse events often reveal that users misunderstood or failed to find labeling information.
• Trend analysis may highlight a need for clearer warnings, contraindications, or step-by-step instructions.
• Field safety corrective actions (FSCA) can involve urgent labeling updates and distribution of new IFUs or safety notices.
• Regulators expect traceable linkage from PMS findings to labeling changes and back into risk files.

Labeling that never changes despite ongoing PMS activity is usually a sign that the feedback loop is broken or purely cosmetic.

11) Common Labeling Errors & Audit Findings

• Inconsistent information: IFU, outer box, and device label give conflicting indications, claims, or warnings.
• Uncontrolled translations: local language labels not aligned with the approved source text.
• Missing or incorrect UDI: mis-encoded barcodes or mismatched DI/PI vs. registration databases.
• Unvalidated reprocessing instructions: cleaning/sterilization IFU content not backed by validation data.
• Stale labels: labels that do not reflect the current design, risk profile, or regulatory commitments.
• Human-factors failures: critical warnings lost in cluttered design or tiny fonts.

Auditors and inspectors often use labeling as a quick window into the health of the entire QMS; repeated labeling issues suggest weak design control, risk management, and document control.

12) Labeling & the Packaging Line – Where Errors Happen

Many labeling failures arise not in the regulations or artwork, but on the packaging line:

• Wrong label roll loaded (mix-ups between similar SKUs or languages).
• Incorrect serialization or UDI data pulled from upstream systems.
• Manual over-labeling or rework not properly documented.
• Line clearance failures leaving old labels in the area.

Controlling these risks requires clear line-clearance procedures, label verification (manual or automated), and connections between ERP/MES and line equipment so that correct data, lots, and UDI codes are applied every time.

13) How Labeling Medical Devices Fits with V5 by SG Systems Global

Integrated labeling data at the point of use. The V5 platform connects labeling rules to real-time manufacturing, packaging, and warehouse operations. Device identity, UDI, batch/serial numbers, and language requirements are driven from controlled master data—not from ad-hoc spreadsheets.

Controlled label templates and change management. Label layouts, content, and print parameters can be managed under Document Control in V5. When RA/QA approve a labeling change, V5 can push new templates and data to packaging workstations, while locking out obsolete versions.

Line-level verification and eDHR linkage. V5’s MES layer records exactly which labels, UDI values, and language variants were applied to each batch or serial, embedding that evidence in the eDHR. Scanning and in-process checks can block release if labeling or UDI is incomplete or inconsistent.

Feedback loop from field to line. Complaints and nonconformances related to labeling can raise CAPA in V5, which can in turn trigger updates to label text, symbols, or line procedures. This closes the loop between PMS, risk management, and packaging operations.

Audit-ready labeling history. During inspections, V5 lets quality and regulatory teams show for any device: the exact label version used, the UDI applied, who applied it, and which controls verified it—without scrambling through paper logs or uncontrolled files.

Bottom line: Labeling is where regulatory intent meets real-world use. V5 helps ensure that the labels patients and clinicians see are accurate, current, and fully traceable back to the QMS and technical documentation.

14) FAQ

Q1. What exactly is included in “medical device labeling”?
Labeling covers all information supplied by the manufacturer: device and packaging labels, IFU/eIFU, on-screen instructions, app content, safety leaflets, and sometimes marketing materials if they influence safe and effective use.

Q2. How tightly should labeling be linked to risk management?
Very tightly. Many risk controls are implemented via warnings, contraindications, and instructions in labeling. Risk files should show how specific risks are mitigated through labeling, and PMS should confirm whether those controls are effective.

Q3. Do software and SaMD products need IFUs and labeling?
Yes. Software needs labeling that explains intended purpose, system requirements, user roles, cybersecurity considerations, limitations, and update behavior. For SaMD, on-screen content and online help are part of the labeling package.

Q4. How often should labeling be updated?
There is no fixed interval. Labeling must be updated whenever there are relevant changes to design, indications, risk profile, regulatory expectations, UDI, or significant PMS findings. A QMS-controlled change process should govern timing and scope.

Q5. Can we rely on automated translation tools for labeling?
Not on their own. Automated tools can assist, but final labeling in each language must be reviewed and approved under the QMS, ideally by native speakers with regulatory awareness. Mis-translations of warnings or indications are high-risk.

Q6. How do labeling controls show up in audits?
Auditors routinely sample labels, IFUs, and DHR/eDHR records to verify consistency, version control, translation management, and UDI accuracy. Labeling issues often trigger broader questions about design control, PMS, and document control.

Related Reading
• Core QMS & Risk: ISO 13485 Requirements | Quality Management System (QMS) | Risk Management (QRM) | Post-Market Surveillance (PMS)
• Device Records & UDI: Device History Record (DHR) | eDHR Software | Unique Device Identification (UDI)
• Regulatory & Market Access: CE Marking | Notified Body (NB) | Declaration of Conformity (DoC)
• Digital Execution: MES | WMS | Audit Trail (GxP)