Medical Device Labeling Services
Arterex Medical is a medical device manufacturer and regulatory services partner delivering comprehensive medical device labeling services to manufacturers across global markets. From initial label design to final regulatory submission, we manage every stage of the labeling lifecycle — ensuring every device that leaves your facility carries accurate, compliant, and patient-safe labeling.
Medical device labeling is far more than printed text on a package. It is a tightly regulated system of information — covering primary device labels, outer packaging, Instructions for Use (IFU), electronic IFU (eIFU), UDI barcodes, regulatory symbols, and multi-language translations. Every element must comply with a layered framework of regional regulations and international standards, including FDA 21 CFR Part 801, EU MDR 2017/745, IVDR 2017/746, UKCA, TGA, and NMPA requirements.
Our services span label design and development, regulatory compliance review, symbol selection under ISO 15223-1:2021, IFU and eIFU development, UDI labeling under 21 CFR Part 830 and EU MDR Article 27, multi-language localization, label artwork management, and digital labeling solutions. We support Class I, II, and III medical devices, IVDs, and Software as a Medical Device across all major therapeutic areas.
Every project at Arterex Medical runs within an ISO 13485:2016-aligned quality management system, integrating ISO 14971:2019 risk management and IEC 62366-1:2015 usability engineering principles into every label and document we produce. Our quality processes align with MDSAP audit criteria, supporting manufacturers targeting the US, EU, Canada, Australia, Brazil, and Japan simultaneously.
When you work with Arterex Medical, you gain more than a labeling vendor — you gain a regulatory partner committed to getting your device to market faster, safer, and fully compliant.
What Medical Device Labeling Services Do We Offer?
We provide end-to-end medical device labeling services — covering everything from initial design to regulatory-compliant final output. Whether you’re launching a new device or updating an existing product line, our team handles the full labeling lifecycle.
Label Design & Development
We design clear, compliant medical device labels aligned with 21 CFR Part 801 for the US market and EU MDR 2017/745 Annex I, Chapter III for Europe. Every layout follows ISO 13485:2016 quality management requirements, balancing regulatory accuracy with real-world readability for clinicians and end users.
Regulatory Compliance Review
Our specialists audit your labels against 21 CFR Part 801, 21 CFR Part 820.120, EU MDR Annex I, and IVDR 2017/746 requirements. We identify compliance gaps before submission, reducing rejection risk and ensuring your labels meet all applicable market-entry standards across every target region.
Symbol Selection & Standardization
We apply globally recognized symbols compliant with ISO 15223-1:2021 and IEC 60601 to replace verbose text and improve cross-border clarity. Per EU MDR Annex I, Chapter III, every symbol must conform to harmonized standards — we ensure full compliance across all international markets.
Instructions for Use (IFU) Development
We write and format IFUs compliant with IEC 62366-1:2015 for usability engineering and EU MDR Article 10, Annex I, Chapter III. Each IFU is structured for its intended audience — clinical professionals or patients — ensuring safe, accurate device use in every market you serve.
Unique Device Identification (UDI) Labeling
We integrate GS1 and HIBC barcodes directly into your label artwork, meeting FDA 21 CFR Part 830 and EU MDR Article 27 UDI requirements. Every label includes the correct UDI-DI and UDI-PI, with full registration support for GUDID in the US and EUDAMED in the EU.
Multi-Language & Localization Services
We translate and localize labels for global markets, meeting FDA English-language requirements and EU MDR obligations across up to 24 official EU member state languages. Every translation is reviewed by regulatory-familiar subject-matter experts, ensuring linguistic accuracy and full market-specific compliance without compromising technical meaning.
Label Artwork Management
We manage version control, change tracking, and approval workflows under ISO 13485:2016 QMS requirements. Our structured process creates a single, auditable system for all label changes — reducing errors across product updates, SKU variations, and regulatory revisions from initiation through final release.
Digital & Electronic Labeling (eIFU)
We develop eIFU solutions compliant with EU Regulation 207/2012 and FDA guidance on electronic instructions. Our digital labeling approach ensures patients and clinicians always access the most current device instructions online — reducing print costs, supporting sustainability goals, and maintaining full regulatory compliance.
What Are the Types of Medical Device Labeling Services?
Medical device labeling covers far more than a printed sticker. Every label, document, and symbol attached to a device — physically or digitally — must meet strict regulatory standards. Here are the core types of medical device labeling services:
- Primary Device Labeling
Primary labeling refers to all text, symbols, and information printed directly on the device or its immediate packaging. It includes the device name, manufacturer details, lot number, expiry date, UDI barcode, and applicable warning symbols — all governed by 21 CFR Part 801 and EU MDR Annex I.
- Secondary & Outer Packaging Labeling
Secondary labeling covers the outer box or carton that houses the device. It must mirror key primary label details while adding shipping, storage, and handling information. EU MDR 2017/745 and ISO 11607 require secondary packaging labels to remain legible and intact throughout the entire distribution chain.
- Instructions for Use (IFU) & User Manuals
IFUs are standalone documents providing step-by-step guidance on safe device operation, maintenance, and disposal. They must comply with IEC 62366-1:2015 for usability, EU MDR Article 10, and ISO 20417:2021 — which specifically governs information to be supplied by the medical device manufacturer.
- Electronic Instructions for Use (eIFU)
eIFUs deliver device instructions digitally via a website or QR code instead of a printed insert. They must comply with EU Regulation 207/2012 and FDA electronic labeling guidance — reducing print costs while ensuring users always access the most current, up-to-date version of the document.
- Regulatory & Compliance Labeling
This covers jurisdiction-specific marks and declarations required to legally sell a device in a given market. Examples include FDA 510(k) clearance references, CE marking under EU MDR 2017/745, UKCA marking for Great Britain, and TGA conformity marks for Australia — each with distinct labeling obligations.
- UDI (Unique Device Identification) Labeling
UDI labeling assigns a globally unique identifier to every device and its packaging. It must include both a UDI-DI and UDI-PI in human-readable and barcode format — compliant with FDA 21 CFR Part 830, EU MDR Article 27, and encoded using GS1 or HIBC issuing agency standards.
- Symbol-Based Labeling
Symbol labeling replaces lengthy text with internationally recognized icons to communicate warnings, storage conditions, sterility status, and handling requirements. Symbols must be sourced from ISO 15223-1:2021, IEC 60601, or ASTM F2503 — ensuring consistent interpretation across all global markets without language barriers.
- Sterility & Single-Use Labeling
Devices that are sterile or intended for single use require specific labeling declarations under ISO 11135 and ISO 11607. Labels must clearly communicate sterilization method, expiry of sterility, and single-use warnings — critical information that directly impacts patient safety and post-market surveillance obligations.
- In Vitro Diagnostic (IVD) Device Labeling
IVD labeling follows a distinct regulatory pathway under EU IVDR 2017/746 and FDA 21 CFR Part 809. Labels must include intended use, specimen type, performance characteristics, and calibration details — ensuring laboratory professionals and point-of-care users can interpret results safely and accurately.
- Software & Digital Device Labeling (SaMD)
Software as a Medical Device requires labeling that clearly defines its intended purpose, classification, and version. FDA guidance on SaMD and EU MDR Article 2(1) both require transparent disclosure of software function, limitations, and cybersecurity considerations — ensuring users understand exactly what the software does and does not do.
Medical Device Labeling Requirements
Medical device labeling is one of the most tightly regulated aspects of bringing a device to market. Every label, symbol, IFU, and packaging element must comply with a layered framework of regional regulations and international standards. Here is what manufacturers need to know.
1. FDA Requirements — United States
The FDA governs all medical device labeling in the US under three interconnected regulations.
21 CFR Part 801 — General Labeling
This is the primary FDA regulation for device labeling. It requires every label to include the manufacturer’s name and place of business, adequate directions for use, and truthful, non-misleading statements. Per Section 801.1, the manufacturer’s full name and address must appear on the label. Per Section 801.5, directions for use must be written clearly enough for a layperson to use the device safely. Per Section 801.15, all labeling must be legible, prominent, and appropriately placed.
21 CFR Part 820.120 — Quality System Labeling Controls
This section requires manufacturers to establish and maintain documented procedures for all labeling activities. Labels must be controlled, verified, and released only after confirming they are accurate and applicable to the correct device version — integrated within the Quality Management System.
21 CFR Part 830 — Unique Device Identification (UDI)
Every device label and package must carry a UDI that includes both a Device Identifier (DI) and a Production Identifier (PI). UDI data must be submitted to the FDA’s Global Unique Device Identification Database (GUDID). GS1 and HIBC are the two FDA-recognized issuing agencies for UDI codes.
2. EU Requirements — European Market
The European Union applies a more demanding framework than its predecessor, the MDD 93/42/EEC, requiring greater transparency of safety and clinical data directly on the label.
EU MDR 2017/745 — Medical Device Regulation
Annex I, Chapter III, Section 23.2 defines mandatory label content for all EU market devices. This includes the device name, manufacturer name and address, lot or serial number, manufacturing date, expiry date, UDI carrier (both AIDC barcode and human-readable format), CE marking with Notified Body number, and an indication that the product is a medical device. Per Article 10(11), labels must be provided in the official language(s) of the EU member state where the device is distributed.
EU IVDR 2017/746 — In Vitro Diagnostic Regulation
IVD devices follow a parallel but distinct labeling pathway under IVDR 2017/746, Annex I, Chapter III. Labels must additionally include the device’s intended use, specimen type, performance characteristics, and calibration details — requirements that go beyond standard MDR labeling.
EU UDI Requirements — Articles 27, 28, 29 & Annex VI
EU MDR requires UDI carriers on the device itself and all higher levels of packaging. The Basic UDI-DI must be registered in EUDAMED before the device is placed on the EU market. Manufacturers, authorised representatives, and importers must all register in EUDAMED and obtain a Single Registration Number (SRN).
EU Regulation 207/2012 & Commission Implementing Regulation 2021/2226 — eIFU
These regulations govern electronic instructions for use, permitting manufacturers to provide IFUs digitally for professional users — provided a paper IFU is available on request and the device label carries the relevant web address or QR code.
3. International Standards — Global Compliance
Beyond regional regulations, the following international standards define how labeling must be designed, controlled, and maintained across all markets.
ISO 13485:2016 — Quality Management Systems
ISO 13485 is the global QMS standard for medical device manufacturers. It requires documented procedures for label design, version control, change management, and release. All labeling activities must be traceable and controlled within the QMS framework. This standard was reviewed and confirmed as current in 2025.
ISO 15223-1:2021 — Medical Device Symbols
This standard defines all internationally recognized symbols that can appear on medical device labels and packaging — including symbols for sterility, single use, lot number, expiry date, and storage conditions. EU MDR Annex I, Chapter III (23.1h) requires that all symbols used conform to harmonized standards such as ISO 15223-1:2021.
ISO 20417:2021 — Information Supplied by the Manufacturer
This standard specifies exactly what information manufacturers must supply with their devices — covering IFUs, technical descriptions, intended purpose, and proper use instructions. It replaced ISO 15223-2 and directly supports EU MDR Annex I, Chapter III compliance.
ISO 14971:2019 — Risk Management
Risk management directly shapes labeling content. ISO 14971 requires manufacturers to identify hazards, evaluate risks, and implement controls — including labeling warnings and contraindications — throughout the device lifecycle. All label warnings and precautions must trace back to a documented risk control measure under this standard. ISO 14971 was reviewed and confirmed as current in March 2025.
IEC 62366-1:2015+AMD1:2020 — Usability Engineering
IFUs and label content must be designed for the intended user in the intended use environment. IEC 62366-1 governs usability engineering for all medical devices, requiring both formative and summative usability assessment. This standard ensures that users — whether clinicians or patients — can safely interpret and act on label information.
ISO 11607 — Packaging for Terminally Sterilized Medical Devices
This standard governs labeling requirements for sterile device packaging. Labels on sterile packaging must clearly communicate the sterilization method, sterility maintenance conditions, and an indication that allows users to recognize the packaging as sterile — referenced directly in EU MDR Annex I, GSPR 23.3.
ISO/IEC 15415 & 15416 — Barcode Print Quality
These standards govern the print quality of 2D and linear barcodes used in UDI labeling. Barcode quality must meet defined grades to ensure reliable scanning throughout the supply chain and at point of care.
4. Other Market-Specific Requirements
UKCA Marking — Great Britain
Following Brexit, devices sold in Great Britain require UKCA marking in place of CE marking, governed by the UK MDR 2002 (as amended). Labeling must carry the UKCA mark, the UK Responsible Person’s details, and comply with MHRA guidance on label content.
TGA — Australia
The Therapeutic Goods Administration (TGA) requires device labels to comply with the Therapeutic Goods (Medical Devices) Regulations 2002. Labels must include the ARTG number, sponsor details, and comply with Australian-specific language and format requirements.
NMPA — China
The National Medical Products Administration (NMPA) requires device labels in Simplified Chinese, including a Chinese registration certificate number and compliance with GB standards for labeling content and symbol use.
Health Canada — Canada
Medical devices sold in Canada must comply with the Medical Devices Regulations (SOR/98-282), requiring bilingual labeling in English and French for all mandatory label elements.
Why Choose Arterex Medical for Medical Device Labeling Services?
Choosing the right labeling partner directly impacts your regulatory approval timeline, product safety record, and market access speed. Here is why medical device manufacturers trust Arterex Medical for their labeling needs.
1. Deep Regulatory Expertise Across Global Markets
Our team understands the full regulatory landscape — FDA 21 CFR Part 801, EU MDR 2017/745, IVDR 2017/746, UKCA, TGA, and NMPA requirements. We don’t just design labels; we build labeling strategies that hold up under regulatory scrutiny in every target market from day one.
2. End-to-End Labeling Services Under One Roof
Arterex Medical handles every stage of the labeling lifecycle — from concept design and symbol selection to IFU development, UDI integration, multi-language translation, and eIFU delivery. One partner, one workflow, zero gaps between services.
3. ISO 13485:2016-Aligned Quality Management
Every labeling project at Arterex Medical is managed within an ISO 13485:2016-aligned quality framework. That means documented procedures, version-controlled artwork, traceable change records, and auditable approval workflows — the exact evidence trail regulators and auditors expect to see.
4. UDI Compliance From Label to Database
We manage the full UDI process — designing GS1 and HIBC-compliant barcodes, integrating UDI-DI and UDI-PI elements into label artwork, and supporting GUDID and EUDAMED registration. Our team ensures your UDI labeling is accurate, scannable, and fully compliant before your device reaches the supply chain.
5. Fast Turnaround Without Compliance Shortcuts
Speed matters in device commercialization. Arterex Medical delivers labeling projects on aggressive timelines without cutting corners on accuracy or compliance. Our structured workflows reduce back-and-forth cycles, compress review timelines, and keep your product launch on schedule.
6. A True Regulatory Partner — Not Just a Vendor
Arterex Medical works as an extension of your regulatory and quality team. We proactively flag labeling risks, stay current with regulatory updates, and provide guidance — not just deliverables. When regulations change, we make sure your labels change with them before it becomes a compliance problem.
Our Certifications for Medical Device Labeling Services
At Arterex Medical, our certifications are not just credentials on a wall — they are active proof that every labeling service we deliver meets the highest standards of quality, safety, and regulatory compliance. Here is what we hold and what it means for you.
ISO 13485:2016 — Medical Device Quality Management System
This is the foundational certification for any credible medical device labeling partner. ISO 13485:2016 requires documented procedures, version-controlled processes, traceable change records, and auditable approval workflows across every stage of labeling. As confirmed by ISO, this standard is designed for organizations involved in the design, production, and servicing of medical devices and related services — which includes labeling providers. Every labeling project at Arterex Medical runs within this certified QMS framework.
FDA Registration & 21 CFR Part 820 / QMSR Compliance
Arterex Medical operates in alignment with FDA’s Quality Management System Regulation (QMSR), which came into full effect on February 2, 2026. The QMSR incorporates ISO 13485:2016 by reference into 21 CFR Part 820, setting the compliance bar for all US-market labeling activities. Our processes — covering label design, version control, and release procedures — are built to satisfy QMSR requirements and withstand FDA inspection scrutiny.
EU MDR 2017/745 & IVDR 2017/746 Compliance Readiness
We maintain full working knowledge of EU MDR and IVDR labeling obligations under Annex I, Chapter III. Our team develops and reviews labels that meet CE marking requirements, UDI-DI and UDI-PI integration for EUDAMED, and all multi-language obligations across EU member states. Clients targeting the European market receive labeling deliverables that are audit-ready for Notified Body review.
MDSAP-Aligned Quality Processes
The Medical Device Single Audit Program (MDSAP) allows a single QMS audit to satisfy regulatory requirements across five major markets — the US FDA, Health Canada, Australia’s TGA, Brazil’s ANVISA, and Japan’s MHLW/PMDA. Our internal quality processes are aligned with MDSAP audit criteria, supporting manufacturers who hold or are pursuing MDSAP certification. This alignment reduces friction when our labeling outputs are reviewed as part of your broader MDSAP audit scope.
ISO 14971:2019 — Risk Management Integration
Our labeling process formally integrates ISO 14971:2019 risk management principles. Every warning, contraindication, and precautionary statement we include on a label traces back to a documented risk control measure. This traceability is essential for both technical file submissions and post-market surveillance obligations under EU MDR and FDA QMSR requirements.
IEC 62366-1:2015+AMD1:2020 — Usability Engineering Compliance
We apply IEC 62366-1 usability engineering principles to every IFU and label we develop. Label content is structured and validated for the intended user in the intended use environment — ensuring that clinicians, patients, and lay users can safely interpret and act on label information. This compliance is directly required under EU MDR Annex I, General Safety and Performance Requirement 5.
ISO 15223-1:2021 — Medical Device Symbols
All symbols used in our label designs are sourced and verified against ISO 15223-1:2021 — the globally recognized standard for medical device symbols. Correct symbol application reduces misinterpretation across international markets and satisfies EU MDR Annex I, Chapter III (23.1h), which requires all symbols to conform to harmonized standards.
ISO 20417:2021 — Information Supplied by the Manufacturer
Our IFU development service is governed by ISO 20417:2021, which defines the specific information manufacturers must supply with their devices. This standard replaced ISO 15223-2 and directly supports technical file completeness for EU MDR and IVDR submissions. Every IFU we produce is structured and reviewed against its requirements.