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Complete Artwork & Labeling Services Portfolio
Freyr offers a complete medical device artwork & labeling service portfolio supporting the end-to-end lifecycle of labeling and packaging artworks across global markets. Our services include label content management, UDI implementation, IFU development (printed and digital), multilingual artwork creation, packaging design, artwork adaptation, proofreading and quality checks, change control, version management, regulatory compliance support, and artwork workflow management. Leveraging domain expertise, standardized processes, and technology-enabled solutions, Freyr ensures compliant, accurate, and market-ready labeling artworks while improving operational efficiency, traceability, and right-first-time delivery for medical device manufacturers.
Our regulatory artwork and labeling services cover the complete spectrum of medical device labeling and packaging requirements, including UDI label development, IFU and eIFU creation, artwork management, and labeling compliance support. With expertise in EU MDR requirements and ISO standards for medical device labeling, we help manufacturers maintain accuracy, consistency, and regulatory compliance throughout the product lifecycle.
Freyr’s Regulatory Artwork and Labeling Services
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Label & Packaging Artwork Creation
Design and development of compliant, market-ready labels and packaging artworks for medical devices, aligning with brand guidelines, regulatory & symbol requirements
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Multilingual Label Artwork Development
Creation of labels and device cartons in multiple languages for pan-European, APAC, and global market submissions, ensuring linguistic accuracy, layout integrity, and regulatory consistency across all language variants
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UDI Label Development
Expert development of Unique Device Identifier (UDI) labels compliant with EU MDR Article 27, FDA 21 CFR Part 830, and IMDRF guidelines, including HIBC, GS1 barcode implementation and EUDAMED alignment.
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IFU / eIFU Development Services
Authoring and design of Instructions for Use (IFU) in print-ready and electronic formats (eIFU) aligned with EU Regulation (EU) 207/2012 and MDR Annex I, enabling paperless compliance for eligible devices.
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Artwork Proofreading & Quality Control
Structured proofreading and quality control of label artwork against approved text, design briefs, and regulatory standards, ensuring zero-error, right-first-time releases with documented review trails.
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Label Artwork Lifecycle Management
End-to-end management of labels, IFUs/eIFUs, packaging artwork, and UDI content to ensure global regulatory compliance, accuracy, and efficient change control. Services include artwork creation, proofreading, multilingual localisation, version management, and print compliance to deliver right-first-time labeling for global markets.
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Medical Device Labeling Consultancy
Optimising the lifecycle of medical device labels, IFUs/eIFUs, packaging artwork, and UDI content through effective label governance, multilingual content management, and LMS/technology assessment to enable compliant, efficient, and scalable global labeling operations.
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Medical Device Symbol Management
Comprehensive management and application of standardised medical device symbols in line with ISO 15223-1, ANSI/AAMI, and market-specific standards ensuring correct, consistent, and defensible symbol usage across all labels and packaging artworks.
A Proven, Streamlined Process
Every Freyr labeling engagement follows a structured, quality-gated workflow that ensures compliance and clarity at every stage.
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Discovery & Briefing
We understand your device, target markets, and labeling requirements in detail before any label development or IFU design work begins.
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Label Artwork Development
Regulatory-led label and artwork design developed against approved content, brand assets, and applicable country standards.
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Quality Control & Proofreading
Structured quality review with comparative checks against source content and documented review records.
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Client Approval
Collaborative review cycles with your regulatory and marketing teams, with tracked revision history.
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Release & Handover
Final label and IFU files and full documentation released into your QMS or archive with complete change history.
Tailored for B2B & B2C Medical Device Markets
Freyr delivers operational excellence across both business models, understanding that label artwork requirements, compliance stakes, and communication goals differ significantly between professional and consumer markets.
B2B — Business to Business
- Complex multi-market regulatory artwork for OEM devices and components
- High-volume label versioning & change management across supply chains
- Artwork for hospital-grade devices with strict MDR/FDA compliance
- IFU documentation aligned with IVDR and MDR Annex I requirements
- Integrated label lifecycle management in existing QMS workflows
B2C — Business to Consumer
- Packaging artwork for OTC devices compliant with retail labeling norms
- Consumer-facing IFU and quick-start guide design for usability clarity
- Multilingual label development for retail and e-commerce channels
- Symbol-led design aligned with ISO 15223 for non-specialist audiences
- eIFU portals enabling a paperless in-box experience for digital audiences
- Accessible design & readability testing for patient-facing materials
Freyr combines deep regulatory expertise with operational efficiency and quality systems, making us uniquely positioned to support medical device companies at every stage of their labeling journey.
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Specialised Medical Device labeling expertise
Freyr understands the unique complexities of medical device labeling, including device labels, IFUs, UDI labels, multilingual adaptation, symbol management, version control, and global labeling requirements.
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End-to-End Labeling Lifecycle Support
Freyr provides complete support across the entire label artwork lifecycle, includes, label content coordination, label and IFU development, label updates and revision, QC of label and IFUs, regulatory compliance verification and change control requirements.
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Strong Regulatory and Compliance Focus
Freyr helps medical device companies maintain compliance with evolving global regulations and standards. Has strong competency in EU MDR, FDA 21 CFR, ISO 13485, and other regulatory requirements. Ensures structured workflow process, maintains audit-ready processes and has a controlled document management ecosystem.
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Technology-enabled efficiency
We leverage purpose-built artwork management platforms and digital workflows to reduce cycle times, eliminate manual errors, and accelerate time-to-market.
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Scalable, flexible engagement models
Whether you need project-based support, a dedicated artwork team, or full outsourcing of your labeling operations, Freyr adapts to your business model.
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Global reach, local expertise
Presence across the US, EU, APAC, and MENA enables us to support simultaneous multi-market label submissions with in-region regulatory insights.
Preguntas frecuentes
01. What are Medical device Artwork & labeling services?
Medical device Artwork & labeling services involve the creation, management, updating, and maintenance of labels, packaging artworks, Instructions for Use (IFUs), eIFUs, and UDI-related content for medical devices. These services help manufacturers ensure compliance with global regulatory requirements while maintaining accuracy, consistency, and traceability throughout the product lifecycle.
02. Why is UDI label development important for medical device manufacturers?
Unique Device Identification (UDI) labels are critical for device traceability, patient safety, and regulatory compliance. Regulatory authorities such as the FDA and the European Union require UDI implementation to improve post-market surveillance, facilitate recalls, and enhance transparency across the medical device supply chain.
03. How can multilingual label artwork support global market access?
Multilingual label artwork enables manufacturers to meet country-specific language requirements while maintaining regulatory consistency across regions. Proper translation, layout adaptation, and quality control help ensure compliance with regulations in Europe, APAC, the Middle East, and other global markets, reducing the risk of labeling errors and market entry delays.
04. What regulations and standards govern medical device labeling and artwork?
Medical device labeling must comply with various global regulations and standards, including EU MDR 2017/745, EU IVDR 2017/746, FDA 21 CFR requirements, ISO 13485, ISO 15223-1 for symbols, Health Canada regulations, TGA Australia requirements, and other country-specific labeling frameworks. Compliance helps ensure product safety, regulatory approval, and uninterrupted market access.
05. Why should manufacturers choose Freyr for Medical device Arteork & labeling services?
Freyr combines deep regulatory expertise, proven quality systems, and technology-enabled workflows to deliver end-to-end label artwork solutions. From label and packaging artwork creation to UDI implementation, IFU/eIFU development, multilingual localization, proofreading, and lifecycle management, Freyr helps manufacturers achieve regulatory compliance, operational efficiency, and faster global market access through scalable and flexible engagement models.