Packaging & Labeling
Comprehensive packaging and labeling solutions for medical devices and combination products — from regulatory label content and UDI carrier placement through sterile barrier system validation, multi-language artwork management, and full compliance with EU MDR, FDA 21 CFR 801, and ISO 11607.
Overview
Packaging and labeling are among the most scrutinized elements of medical device regulatory compliance, serving as the primary interface between the manufacturer, the end user, and the regulatory authority. Under EU MDR 2017/745, labeling encompasses the label on the device itself, the packaging at every level, and the Instructions for Use (IFU) — all of which must convey mandatory information including the UDI carrier, CE marking, manufacturer and importer identification, and device-specific safety data. Non-compliant labeling is one of the most common findings during notified body audits and market surveillance inspections, frequently resulting in corrective action requests, certificate suspensions, or forced market withdrawals.
Swiss MPC provides end-to-end packaging and labeling services that address the full spectrum of regulatory requirements across EU, US, and international markets. Our consultants have developed labeling systems for Class I through Class III devices spanning surgical instruments, implantable technologies, in vitro diagnostics, sterile disposables, and software as a medical device. We understand the complex interplay between labeling regulations, UDI requirements, packaging validation standards, and the practical constraints of multi-market distribution — including the challenge of accommodating up to 24 EU languages on a single label or multi-panel booklet.
For sterile medical devices, packaging serves a critical dual function: it must protect the device during transport and storage while maintaining the sterile barrier until the point of use. Our expertise in ISO 11607 sterile barrier system design, material selection, sealing process validation, and accelerated aging studies ensures that your packaging meets both regulatory and functional performance requirements. We coordinate packaging validation activities with your sterilization process to deliver an integrated, compliant sterile presentation system.
Swiss MPC also supports manufacturers of pharmaceutical combination products — devices co-packaged or integrated with medicinal products — where labeling must satisfy both medical device regulations (EU MDR or FDA 21 CFR 801) and pharmaceutical labeling requirements simultaneously. We navigate the complex regulatory boundaries between device and drug labeling, ensuring that combination product packaging meets the expectations of both notified bodies and competent authorities for medicinal products.
Common Packaging & Labeling Challenges
Multi-Language Label Compliance
EU MDR requires that labeling information be provided in the official language(s) of each Member State where the device is made available. For manufacturers distributing across the EU, this can mean accommodating up to 24 languages on labels with limited physical space. Balancing regulatory content requirements — including UDI, lot/batch, expiry date, warnings, and device-specific information — across multiple languages while maintaining legibility and production efficiency is a persistent challenge that demands careful typographic planning and innovative label formats such as multi-panel booklet labels or peel-back constructions.
UDI Carrier Integration and Placement
EU MDR Article 27 and FDA 21 CFR 801 require that UDI carriers — both human-readable and machine-readable (AIDC) formats — appear on every packaging level, from the unit of use through cases and shipping containers. Integrating barcodes and human-readable identifiers into existing label designs without compromising readability, scan reliability, or aesthetic quality requires expertise in symbology selection, print process capabilities, and barcode verification standards (ISO/IEC 15415, ISO/IEC 15416).
Sterile Barrier System Validation
Sterile medical device packaging must maintain its barrier integrity through manufacturing, sterilization, distribution, and storage until the point of use. ISO 11607-1 and ISO 11607-2 require validation of the packaging system including seal strength testing, microbial barrier properties, and stability through accelerated and real-time aging studies. Manufacturers frequently underestimate the scope and duration of packaging validation, particularly when changes to materials, sealing equipment, or sterilization methods trigger revalidation requirements.
Hazardous Substance and CMR Labeling
EU MDR Annex I, Section 10.4 requires that devices containing substances classified as carcinogenic, mutagenic, or toxic to reproduction (CMR) above 0.1% w/w, or endocrine-disrupting substances, must include specific labeling disclosures. Identifying applicable substances across complex device bills of materials, determining concentration thresholds, and integrating the required hazard information into label content demands cross-functional coordination between regulatory affairs, materials engineering, and supply chain teams.
Artwork Management Across Product Portfolios
Large medical device manufacturers may maintain hundreds or thousands of label and IFU artwork files across product families, language variants, and market-specific configurations. Managing artwork revisions, ensuring version control, coordinating translations, and maintaining traceability between approved artwork and production output requires robust artwork management systems and procedures integrated into the quality management system. Without disciplined artwork governance, labeling errors proliferate and become a leading source of field safety corrective actions.
Our Packaging & Labeling Approach
Labeling Regulatory Gap Analysis
We conduct a thorough review of your current labels, IFUs, and packaging against the full requirements of EU MDR Annex I Chapter III, FDA 21 CFR 801, and any market-specific labeling regulations applicable to your distribution territories. The gap analysis identifies missing or non-compliant content elements, assesses UDI carrier placement and quality, evaluates symbol usage against ISO 15223-1:2021, and produces a prioritized remediation plan with specific corrective actions for each packaging level and product line.
Label Content Specification and Design
Our regulatory specialists develop comprehensive label content specifications that define every mandatory and optional element for each label variant — including manufacturer and importer details, CE marking with notified body number, UDI carrier specifications, lot/batch and expiry date formats, storage and handling symbols, warnings, and language-specific text blocks. We work with your graphic design and packaging engineering teams to translate these specifications into production-ready artwork that balances regulatory completeness with visual clarity and production feasibility.
Sterile Packaging Design and Validation
For sterile devices, we support the selection and qualification of sterile barrier system materials, seal configurations, and packaging formats in accordance with ISO 11607-1 and ISO 11607-2. Our team develops packaging validation protocols covering seal strength testing (ASTM F88), burst testing (ASTM F2054/F2095), dye penetration testing (ASTM F1929), microbial barrier evaluation, and accelerated aging studies (ASTM F1980). We coordinate validation activities with your sterilization process validation to ensure the complete sterile presentation system is qualified as an integrated unit.
Multi-Language Artwork Development
We manage the end-to-end process of developing multi-language labels and IFUs for pan-European and global distribution. This includes defining language groupings by distribution territory, coordinating regulatory-grade translations with qualified medical translators, specifying typographic requirements for each language (including character sets, minimum font sizes, and reading order), and validating that translated content accurately reflects the approved source text. We also evaluate label format options — single-panel, multi-panel, booklet, and e-IFU strategies — to accommodate language requirements within your packaging constraints.
Artwork Management System Implementation
We help manufacturers establish or optimize artwork management processes within their quality management system, including artwork creation and approval workflows, version control procedures, change management protocols, and traceability between approved artwork masters and production output. For organizations with large product portfolios, we evaluate and recommend artwork management software solutions that automate revision control, translation management, and regulatory content verification to reduce manual errors and accelerate time to market.
Production Integration and Ongoing Compliance
We support the transition from approved artwork to production-ready label output, working with your label printing vendors and packaging suppliers to validate print quality, barcode readability, and material compatibility. Post-implementation, we provide ongoing labeling compliance support including periodic label audits, regulatory change impact assessments (for updates to standards, regulations, or harmonized symbols), and support for notified body and FDA inspections focused on labeling and packaging controls.
Packaging & Labeling Deliverables
- Labeling regulatory gap analysis report with prioritized remediation plan
- Label content specifications for all packaging levels (unit, case, shipper)
- UDI carrier placement and symbology specifications per packaging level
- ISO 15223-1:2021 symbol usage assessment and recommendations
- Multi-language label content matrices with regulatory translations
- Sterile barrier system validation protocols and reports (ISO 11607)
- Accelerated and real-time aging study protocols and reports (ASTM F1980)
- Artwork approval and version control SOPs integrated into QMS
- IFU content specifications and regulatory review documentation
- Combination product labeling compliance assessment
- Barcode verification specifications and print quality acceptance criteria
- Post-implementation label audit report with compliance confirmation
Applicable Standards & Regulations
EU MDR 2017/745 — Annex I, Chapter III
Sections 23 and 24 of the MDR General Safety and Performance Requirements define mandatory labeling and Instructions for Use requirements for medical devices, including content elements, language obligations, CE marking placement, and specific provisions for sterile devices, devices with measurable functions, and devices containing hazardous substances.
FDA 21 CFR Part 801
US federal regulations governing the labeling of medical devices, including general labeling provisions, adequate directions for use, exemptions from adequate directions for use, and specific requirements for in vitro diagnostic products. Part 801 also incorporates UDI labeling requirements established under 21 CFR 801 Subpart B.
ISO 15223-1:2021
International standard specifying symbols and their meaning for use in medical device labeling. ISO 15223-1 provides a standardized symbol library that enables manufacturers to communicate essential safety and handling information independent of language, reducing label complexity for multi-market distribution.
ISO 11607-1 & ISO 11607-2
The two-part international standard for packaging of terminally sterilized medical devices. Part 1 addresses requirements and test methods for materials, sterile barrier systems, and packaging systems. Part 2 addresses validation requirements for forming, sealing, and assembly processes used to produce sterile barrier systems and packaging systems.
EN 1041:2008+A1:2013
European standard specifying requirements for information supplied by the manufacturer of medical devices, including labeling content, IFU structure, and language requirements. EN 1041 provides practical guidance on implementing the labeling obligations defined in the EU MDR and remains a key reference for notified body assessment of labeling compliance.
ASTM F1980 — Accelerated Aging
Standard guide for accelerated aging of sterile barrier systems used in medical device packaging. ASTM F1980 provides the methodology for establishing shelf life claims by subjecting packaging to elevated temperature conditions that simulate extended storage periods, enabling manufacturers to make expiry date claims without waiting for real-time aging data.
EU MDR Article 27 — UDI System
Establishes the Unique Device Identification system requirements for the EU market, mandating UDI carrier placement on device labels and all higher packaging levels. Article 27, together with Annex VI Part C, defines the obligations for UDI-DI and UDI-PI encoding, label formatting, and EUDAMED UDI database registration.
MDCG 2019-7 — Electronic Instructions for Use (e-IFU)
Medical Device Coordination Group guidance on the conditions under which manufacturers may provide Instructions for Use in electronic form rather than paper, applicable to professional-use devices. The guidance defines user notification requirements, website accessibility standards, and the obligation to provide paper IFU upon request without additional cost.
Frequently Asked Questions
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