--- title: "Labeling, Definition | MedTech Terms" description: "All written, printed, or graphic matter on or accompanying a device. Plain-English Regulatory definition for MedTech teams, with examples and related terms." lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/labeling#term", "name": "Labeling", "description": "Per FD&C Act, labeling includes any written, printed, or graphic matter accompanying a medical device, encompassing the IFU, package labels, and patient information leaflets.", "url": "https://medtechterms.com/terms/labeling", "termCode": "labeling", "inDefinedTermSet": { "@type": "DefinedTermSet", "name": "MedTech Terms", "url": "https://medtechterms.com/terms" } }, { "@type": "Article", "@id": "https://medtechterms.com/terms/labeling#article", "headline": "Labeling", "description": "All written, printed, or graphic matter on or accompanying a device.", "url": "https://medtechterms.com/terms/labeling", "mainEntityOfPage": { "@type": "WebPage", "@id": "https://medtechterms.com/terms/labeling" }, "about": { "@id": "https://medtechterms.com/terms/labeling#term" }, "articleSection": "Regulatory", "inLanguage": "en", "keywords": "Labeling, Regulatory, medical device, MedTech", "author": { "@type": "Person", "name": "Christian Espinosa", "jobTitle": "Founder, Blue Goat Cyber", "url": "https://bluegoatcyber.com" }, "publisher": { "@type": "Organization", "name": "MedTech Terms", "url": "https://medtechterms.com" }, "isPartOf": { "@type": "WebSite", "name": "MedTech Terms", "url": "https://medtechterms.com" }, "datePublished": "2026-05-05", "dateModified": "2026-05-05", "citation": [ { "@type": "CreativeWork", "name": "IMDRF Documents", "url": "https://www.imdrf.org/documents", "publisher": { "@type": "Organization", "name": "IMDRF" } }, { "@type": "CreativeWork", "name": "RAPS Regulatory Focus", "url": "https://www.raps.org/news-and-articles/news-articles", "publisher": { "@type": "Organization", "name": "RAPS" } }, { "@type": "CreativeWork", "name": "FDA - Medical Devices", "url": "https://www.fda.gov/medical-devices", "publisher": { "@type": "Organization", "name": "FDA" } } ], "mentions": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/ifu#term", "name": "Instructions for Use", "alternateName": "IFU", "url": "https://medtechterms.com/terms/ifu" }, { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/udi#term", "name": "Unique Device Identification", "alternateName": "UDI", "url": "https://medtechterms.com/terms/udi" } ] }, { "@type": "BreadcrumbList", "itemListElement": [ { "@type": "ListItem", "position": 1, "name": "Home", "item": "https://medtechterms.com/" }, { "@type": "ListItem", "position": 2, "name": "Terms", "item": "https://medtechterms.com/terms" }, { "@type": "ListItem", "position": 3, "name": "Regulatory", "item": "https://medtechterms.com/terms?cat=Regulatory" }, { "@type": "ListItem", "position": 4, "name": "Labeling", "item": "https://medtechterms.com/terms/labeling" } ] }, { "@type": "FAQPage", "@id": "https://medtechterms.com/terms/labeling#faq", "mainEntity": [ { "@type": "Question", "name": "What is the primary purpose of medical device labeling?", "acceptedAnswer": { "@type": "Answer", "text": "The primary purpose is to provide users with essential information for safe and effective device use, including indications, contraindications, warnings, precautions, and operating instructions." } }, { "@type": "Question", "name": "Does promotional material count as labeling?", "acceptedAnswer": { "@type": "Answer", "text": "Yes, under FDA regulations, promotional materials are generally considered part of the device labeling if they accompany the device or are disseminated by the manufacturer in conjunction with the device's sale." } }, { "@type": "Question", "name": "Are electronic Instructions for Use (eIFU) permitted?", "acceptedAnswer": { "@type": "Answer", "text": "Yes, both FDA (e.g., 21 CFR Part 801, Subpart D) and EU MDR (Annex I, Chapter III, Section 23.4) permit eIFU under specific conditions, often requiring a risk assessment and provisions for providing paper copies upon request." } }, { "@type": "Question", "name": "How does cybersecurity relate to labeling?", "acceptedAnswer": { "@type": "Answer", "text": "For devices with cybersecurity features, labeling must clearly communicate cybersecurity-related information, such as recommended security controls, software bill of materials (SBOM), and incident response procedures, as increasingly emphasized by FDA guidance." } } ] } ] } --- [ MedTech Terms The authoritative reference ](/) Browse Learn [Latest](/latest) About 1. [Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Regulatory](/terms?cat=Regulatory) 6. / 7. Labeling [All terms](/terms) Regulatory [Regulated Pathways](/ecosystems/regulated-pathways) # Labeling All written, printed, or graphic matter on or accompanying a device. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed May 5, 2026 ## Definition Per FD&C Act, labeling includes any written, printed, or graphic matter accompanying a medical device, encompassing the [IFU](/terms/ifu), package labels, and patient information leaflets. What the regulation says Under 21 CFR Part 801, FDA defines labeling broadly to include all written, printed, or graphic matter accompanying a device, encompassing items like [instructions for use](/terms/ifu) (IFU), packaging, and promotional materials. Similarly, the EU [MDR](/terms/mdr-reporting) (Regulation (EU) 2017/745) details essential requirements for information supplied with the device in Annex I, Chapter III, emphasizing aspects like symbols, electronic instructions, and language requirements. ## What this means in practice Labeling errors are a leading cause of recalls and Form 483 citations. EU [MDR](/terms/mdr-reporting) adds harmonized symbols and electronic [IFU](/terms/ifu) rules. ## Examples - A manufacturer includes a detailed instruction for use (IFU) booklet inside the medical device packaging, which details operating procedures and maintenance schedules. - The outer carton of a sterile medical device displays a symbol indicating "do not resterilize" and the universally recognized symbol for "use-by date." - A company provides a dedicated section on its website with downloadable electronic Instructions for Use (eIFU) for its diagnostic equipment, accessible after accepting terms and conditions. Common pitfalls - • A common pitfall is assuming labeling only refers to the physical label on the device itself; it includes all accompanying information. - • Companies often fail to translate labeling accurately and appropriately for all target markets, leading to non-compliance. - • Inconsistent information across various labeling components (e.g., IFU, website, promotional materials) can lead to regulatory scrutiny. - • Overlooking the need for version control and proper document management for all labeling elements is a frequent mistake. - • Failing to validate electronic IFU systems for accessibility, readability, and security can result in regulatory issues. ## Frequently asked questions What is the primary purpose of medical device labeling? The primary purpose is to provide users with essential information for [safe](/terms/safe-note) and effective device use, including indications, contraindications, warnings, precautions, and operating instructions. Does promotional material count as labeling? Are electronic Instructions for Use (eIFU) permitted? How does cybersecurity relate to labeling? ## Cross-references ### Uses Concepts or artefacts this term builds on. - [ ISO 15223-1 Symbols ](/terms/iso-15223-1) ### Contains Sub-elements or required artefacts of this term. - [ Electronic Instructions for Use(eIFU) ](/terms/eifu) ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Regulatory Instructions for Use(IFU) Information supplied by the manufacturer to inform the user of safe use of a device. ](/terms/ifu)[ Regulatory Unique Device Identification(UDI) System for adequate identification of medical devices through distribution and use. ](/terms/udi) ### Risk & Usability Deep Dive · From this learning path [ Quality & Risk Summative vs. Formative Evaluation Iterative usability studies (formative) vs. final validation testing (summative) of a device's user interface. Adjacent lesson ](/terms/summative-formative?from=risk-and-usability)[ Clinical & Trials Human Factors Engineering(HFE) Engineering discipline focused on safe and effective device use by intended users. ](/terms/human-factors?from=risk-and-usability)[ Standards IEC 62366-1 Application of usability engineering to medical devices. ](/terms/iec-62366-1?from=risk-and-usability)[ Standards ISO 14971 International standard for the application of risk management to medical devices. ](/terms/iso-14971?from=risk-and-usability) ### More in Regulatory · Same category [ Regulatory 510(k) Premarket Notification(510(k)) FDA submission demonstrating a device is substantially equivalent to a legally marketed predicate. ](/terms/510k)[ Regulatory 510(k) Summary vs 510(k) Statement Two alternative disclosure mechanisms in a 510(k) submission, a Summary is public on FDA's website; a Statement promises to share Safety & Effectiveness info on request. ](/terms/510k-summary-vs-statement) Cited by Where this term appears across MedTech Terms. Learning paths (1) - [Risk & Usability Deep Dive](/paths/risk-and-usability)Lesson 9 of 9 Ecosystems (1) - [Regulated Pathways](/ecosystems/regulated-pathways) ## Mentioned in recent activity 11 entries Recalls (10)PubMed (1) [HydroMARK Breast Biopsy Site Marker, Model Number: 4010-02-15-T3 ](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=Z-2239-2026) Class II · 2026-04-24 [RelayPro Thoracic Stent-Graft System (various sizes) Reference numbers: 28-N4-32-104-32U 28-N4-32-164-28U 28-N4-32-164-32U 28-N4-32-209-28U 28-N4-32-209-32U 28-N4-32-259-32U 28-N4-34-109-34U 28-N4-34-154-30U 28-N4-34-154-34U 28-N4-34-209-30U 28-N4-34-209-34U 28-N4-34-259-34U 28-N4-36-109-36U 28-N4-36-154-32U 28-N4-36-154-36U 28-N4-36-199-32U 28-N4-36-199-36U 28-N4-36-259-36U 28-N4-38-109-38U 28-N4-38-154-34U 28-N4-38-154-38U 28-N4-38-199-34U 28-N4-38-199-38U 28-N4-38-259-38U 28-N4-40-114-40U 28-N4-40-154-36U 28-N4-40-154-40U 28-N4-40-204-36U 28-N4-40-204-40U 28-N4-40-259-40U 28-N4-42-114-42U 28-N4-42-159-38U 28-N4-42-159-42U 28-N4-42-204-38U 28-N4-42-204-42U 28-N4-42-259-42U 28-N4-44-114-44U 28-N4-44-164-40U 28-N4-44-164-44U 28-N4-44-209-40U 28-N4-44-209-44U 28-N4-44-259-40U 28-N4-44-259-44U 28-N4-46-114-46U 28-N4-46-164-42U 28-N4-46-164-46U 28-N4-46-209-42U 28-N4-46-209-46U 28-N4-46-259-42U ](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=Z-2160-2026) Class I · 2026-04-22 [COVIDIEN Shiley Tracheostomy Tube Cuffed with Inner Cannula REF 6FEN UDI-DI code: 60884522007028 The devices are intended for use in providing tracheal access for airway management. Shiley Tracheostomy Tubes are double cannula tracheostomy tubes with reusable inner cannulae (LPC, FEN, CFS, CFN, LGT) and twist-lock connectors. These Shiley Tracheostomy Tubes have a radiopaque, biocompatible outer cannula constructed of polyvinyl chloride. ](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=Z-2261-2026) Class II · 2026-04-15 [TITANIUM/FLUOROPLASTIC PISTON 0.6MM DIA X 3.75MM L Model/Catalog Number: 409-375 Product Description: Stapes Prosthesis ](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=Z-2308-2026) Class II · 2026-04-03 [AIDBAGs are first aid kits of convenience composed of individually labeled devices designed as specialty first aid kits designed for the appropriate level provider to evaluate and treat patients at the point-of-injury / point-of-illness. The original manufacturer labeling, including single use indications, is maintained for each device, which may be used independently and at different times. These specific kits contain the McKesson TRUE Metrix PRO Professional Monitoring Blood Glucose System that were recalled as part of RES 98317 with (510(k): K140100). ](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=Z-1947-2026) Class I · 2026-03-27 [Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO ](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=Z-2172-2026) Class II · 2026-03-27 [Prodisc C SK U.S. IMPLANT EXTRA LARGE 5MM. Model: PDSXL5 Total cervical disc replacement. ](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=Z-2050-2026) Class II · 2026-03-20 [Prodisc C SK U.S. IMPLANT EXTRA LARGE 6MM. Model Number: PDSXL6. Total cervical disc replacement. ](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=Z-2051-2026) Class II · 2026-03-20 [Brand Name: BiDop 3 Product Name: BiDop 3 Pocket Doppler (ES-100V3) with BT2M20S8C fetal probe Model/Catalog Number: ES-100V3 (device); BT2M20S8C (2 MHz fetal probe). Software Version: N/A Product Description: Hand-held, battery-powered ultrasonic Doppler blood-flow detector with LCD numeric display, used with interchangeable probes to detect vascular blood-flow signals and display heart rate; affected units were packaged with a 2 MHz BT2M20S8C fetal probe and labeled for both vascular and fetal applications. ](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=Z-1631-2026) Class II · 2026-03-04 [Cardinal Health Monoject Tuberculin Syringe, 1 mL Luer Lock, Catalog Number 1180100777 ](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=Z-1768-2026) Class II · 2026-02-27 ## Latest in MedTech [View all](/latest?term=labeling) Recent regulatory actions, publications, and trials matched to this term. Updated daily. - PubMed 2026-05-01 [Effects of project management in labeling standardization for new reusable medical device packages: A retrospective study. ](https://pubmed.ncbi.nlm.nih.gov/42130111/) The Journal of international medical research - Recall 2026-04-24 [HydroMARK Breast Biopsy Site Marker, Model Number: 4010-02-15-T3 ](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=Z-2239-2026) Class II · Devicor Medical Products Inc - Recall 2026-04-22 [RelayPro Thoracic Stent-Graft System (various sizes) Reference numbers: 28-N4-32-104-32U 28-N4-32-164-28U 28-N4-32-164-32U 28-N4-32-209-28U 28-N4-32-209-32U 28-N4-32-259-32U 28-N4-34-109-34U 28-N4-34-154-30U 28-N4-34-154-34U 28-N4-34-209-30U 28-N4-34-209-34U 28-N4-34-259-34U 28-N4-36-109-36U 28-N4-36-154-32U 28-N4-36-154-36U 28-N4-36-199-32U 28-N4-36-199-36U 28-N4-36-259-36U 28-N4-38-109-38U 28-N4-38-154-34U 28-N4-38-154-38U 28-N4-38-199-34U 28-N4-38-199-38U 28-N4-38-259-38U 28-N4-40-114-40U 28-N4-40-154-36U 28-N4-40-154-40U 28-N4-40-204-36U 28-N4-40-204-40U 28-N4-40-259-40U 28-N4-42-114-42U 28-N4-42-159-38U 28-N4-42-159-42U 28-N4-42-204-38U 28-N4-42-204-42U 28-N4-42-259-42U 28-N4-44-114-44U 28-N4-44-164-40U 28-N4-44-164-44U 28-N4-44-209-40U 28-N4-44-209-44U 28-N4-44-259-40U 28-N4-44-259-44U 28-N4-46-114-46U 28-N4-46-164-42U 28-N4-46-164-46U 28-N4-46-209-42U 28-N4-46-209-46U 28-N4-46-259-42U ](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=Z-2160-2026) Class I · Bolton Medical Inc. ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 IMDRF· 1 RAPS· 1 FDA· 1 1. [1 IMDRF Documents Verified IMDRF · imdrf.org ](https://www.imdrf.org/documents) 2. [2 RAPS Regulatory Focus Verified RAPS · raps.org ](https://www.raps.org/news-and-articles/news-articles) 3. [3 FDA - Medical Devices Verified FDA · fda.gov ](https://www.fda.gov/medical-devices) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Navigating an FDA or EU MDR submission? Blue Goat Cyber supports the cybersecurity content of premarket submissions, from threat models to the 524B narrative. [Book a 30-minute discovery session](https://go.bluegoatcyber.com/meetings/blue-goat-cyber/discovery-session) - No obligation - Expert-led from minute one - NDA available on request MedTech Terms is a community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com). Definitions are independent of any vendor. On this term Category Regulatory Sources 3 Updated 5/5/2026 [Compare with another term](/compare?a=labeling) Learn in 60 seconds Card Lesson Quiz All written, printed, or graphic matter on or accompanying a device. - · Labeling errors are a leading cause of recalls and Form 483 citations. - · EU MDR adds harmonized symbols and electronic IFU rules. Remember this Watch out: A common pitfall is assuming labeling only refers to the physical label on the device itself; it includes all accompanying information. Related terms - [Instructions for Use(IFU) ](/terms/ifu) - [Unique Device Identification(UDI) ](/terms/udi) You may also need Auto-suggested from Regulatory and shared keywords. - [Summary of Safety and Performance (IVDR)(SSP) ](/terms/ivdr-summary-safety-performance) - [ISO 15223-1 Symbols ](/terms/iso-15223-1) - [Premarket Cybersecurity Submission ](/terms/premarket-cybersecurity) - [Single-Use Device(SUD) ](/terms/single-use-device) - [510(k) Summary vs 510(k) Statement ](/terms/510k-summary-vs-statement) - [513(g) Request for Information(513(g)) ](/terms/513g) [All Regulatory terms](/terms?cat=Regulatory) From the Blue Goat network Related resources and services on this topic. - [ MedTech Cybersecurity Standards Authoritative reference for the standards and guidances behind medical device cybersecurity. ](https://medtechcyberstandards.com) - [ MedTech Cybersecurity Crosswalk International crosswalk of medical device cybersecurity requirements across regulators. ](https://mdccrosswalk.com) - [ MedTech Truths Common misconceptions about medical device development - debunked. ](https://mdcmisconceptions.com) - [ MedTech Launchpad MedTech funding rounds, accelerators, and launch resources. ](https://medtechlaunchguide.com) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. 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