International labelling of medical device (IVD)
1. International overview
The global regulation of labeling for Medical Devices and In Vitro Diagnostic (IVD) Medical Devices is guided by the IMDRF (International Medical Device Regulators Forum), specifically the document Principles of Labeling for Medical Devices and IVD Medical Devices.
This document establishes harmonized principles while providing the necessary flexibility for each market to stipulate country-specific content and language requirements.
The label and Instructions for Use (IFU) serve a purpose far beyond simply informing users and patients. They are critical, controlled documents integrated into every stage of the product lifecycle:
Regulatory & Registration
The IFU and label are fundamental components of the Technical Documentation (Dossier) and are frequently the most requested documents, often leading to deficiency questions from regulators.
Sales & Marketing
All marketing claims must be strictly consistent with the approved Intended Use and Indications for Use detailed in the IFU, requiring clearance from the clinical affairs team.
Customer Support
A robust IFU acts as the primary product reference, enabling users to efficiently find information and helping prevent user errors by providing clear usage instructions.
Product Management
The defined features, functional parameters, and Intended Use originate directly from the product management strategy.
R&D / Engineering
The IFU serves as a formal showcase of all verified design inputs and validated design outputs.
Production
All labels, especially those containing critical warning content and traceability data (e.g., lot/batch), must be accurately generated and applied during the final production stages.
Quality Management
Labeling integrity and accuracy must be verified as part of the final product release inspection.
2. 🌍 Unique Market-Specific Requirements
While ISO 15223-1 provides internationally harmonized symbols, labeling requirements vary significantly by market regarding language, legal entity representation, certification marks, and unique symbols.
Essential Labeling Elements to Consider
Language
Must comply with the official language(s) required by the purchasing country for the IFU and/or the label.
Country specific Symbol
The typical example is the CE Mark in the EU. Note that the FDA does not have a parallel symbol for device clearance. For devices with radio functionality, the symbol of the certified body (e.g., FCC ID in the US, RED requirements in the EU) is often mandatory on the device.
Foreign manufacturers must designate a Legal Contact (e.g., EU Authorized Representative, UK Responsible Person, US Agent, etc.) whose name and address must appear on the label or packaging.
Product Name (model/variant)
Must be provided in the local language and be strictly consistent with the officially registered or certified product name and the IFU.
Symbols
While ISO 15223-1 symbols are generally accepted, some countries may mandate local language text underneath a symbol or require proprietary symbols (e.g., specific country-approved symbols for recycling or electronic waste).
Certification Number
This number (often referencing the product approval or the quality management system certificate) is crucial for inspection by regulators, customers, and across all supply chains.
Key Market Differences
· EU (MDR/IVDR): Mandates the name and address of the Authorized Representative (if applicable), Summary of Safety and Performance (SSP) Reference, basic UDI, and specific language requirements based on the Member State.
· US (FDA): Focuses on clear display of the manufacturer/distributor name and place of business (address). The label must clearly identify the name and place of business (physical address) of the manufacturer, packer, or distributor.
· China (NMPA): Requires all essential labeling, including the IFU, to be in Simplified Chinese. Specific manufacturer and production site information is often mandated on the certificate and label.
· South Korea (MFDS): Requires the IFU to be in Korean and demands specific details of the manufacturer and importer to be included.
Gray Zone: "Nice to Have" vs. Essential Information
Certain information falls into a gray zone, where it is generally not a universal regulatory requirement but may be essential in specific jurisdictions or highly recommended for traceability:
· Distributor Information: Only essential if the distributor also acts as the Legal Person/Authorized Representative in certain territories.
· Outsourced Partner Names: The names of outsourced designers, sterilizers, or producers are generally not required on the label. However, the production site must be explicitly written in the regulatory documentation
· "Made in XX" (Country of Origin): There is no uniform global regulatory definition for "Made In." This is often a Customs or trade requirement rather than a medical device regulation requirement.
3. 🔄 Managing Labeling Changes: Significance Assessment
Unfortunately, there is no single dedicated international guidance that clearly defines what constitutes a significant change to labeling and how to notify authorities for every market. Manufacturers must rely on best practices and market-specific change notification regulations.
Critical Labeling Changes (Require Regulatory Notification)
Based on industry best practice, these changes are nearly always considered critical and require a formal regulatory submission:
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Intended Use or Indication for Use
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Changes to Functional Parameters (e.g., power output, limits)
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Adding, removing, or modifying Claims
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Adding, removing, or modifying a Symbol with Warning Content (e.g., contraindications, use limitations)
Non-Critical Labeling Changes (May Not Require Notification)
These changes are typically considered administrative or editorial and usually do not require regulatory notification (though they must still be documented in the QMS):
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Standard Symbols (e.g., "Do Not Reuse" symbol without changing the meaning)
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Country-Specific Symbols where the mark itself is unchanged (e.g., adding the Notified Body number "CE 0123" if the NB is unchanged)
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Rewording text without altering the meaning, safety information, or functional parameters
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Reformatting or reordering text/figures with a similar meaning
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Updating a Listed Standard (e.g., changing from EN ISO 13485:2016 to EN ISO 13485:2021 in the IFU reference section)
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Packaging label is never a critical besides country specific content as certification number
4. Our service
To effectively manage labeling compliance and minimize time-to-market gaps, manufacturers should leverage the following strategic services:
eIFU (Electronic Instructions for Use) Strategy: Implementing compliant digital distribution models to facilitate rapid, non-critical updates and reduce printing costs/inventory obsolescence, adhering to regulations like EU MDR Annex I, 23.1(f).
Change Assessment of Labeling: Conducting a rigorous Global Impact Assessment (GIA) for every proposed change, classifying it as Major (requires submission) or Minor (internal QMS update) based on the most stringent market's requirements.
Regulatory Proofing of Labeling: Providing expert review of final label and IFU drafts against specific national requirements (language, symbols, local legal entity details) to confirm registration consistency before product release.
Labeling for Registration: Generation and submission of country-specific label and IFU translations to Competent Authorities as part of initial product registration and subsequent license renewals.