ISO 15223-1 specifies symbols that express information about a medical device - such as manufacturer, lot number, sterilization method, and use-by date - supporting global label harmonization. The 2021 edition added symbols needed by the EU MDR and IVDR, such as the 'medical device' (MD) symbol, UDI and importer and distributor symbols. Using symbols from the standard is a way to show conformity with labeling requirements without translating text into every language, but some symbols must be explained in the IFU or accompanying documents. FDA allows standard symbols without adjacent text under 21 CFR 801.15.

Why it matters

Both EU MDR/IVDR and FDA recognize ISO 15223-1 symbols in lieu of explanatory text under specified conditions, simplifying multi-region labeling.

Common pitfalls

•Failing to provide definitions for symbols in accompanying documentation (e.g., Instructions For Use) can lead to non-compliance.
•Using symbols inconsistently across different product lines or regions creates confusion and potential regulatory issues.
•Assuming all symbols are universally understood without considering country-specific regulations or user demographics is a common mistake.
•Neglecting to keep symbol usage updated with the latest revisions of ISO 15223-1 can result in outdated labeling.
•Poor legibility or incorrect placement of symbols on the label can render them ineffective or misleading.

Sources

ISO 15223-1:2021 · ISO
FDA Recognized Consensus Standards · FDA
ISO Standards Catalogue - Health · ISO

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Why compare MedTech terms side by side?

MedTech terminology is full of pairs that look interchangeable but carry very different regulatory, clinical, and commercial consequences. Picking the wrong framework, pathway, or standard early in a project can add months to a submission, invalidate clinical evidence, or trigger an audit finding. Side-by-side comparison is the fastest way to surface those differences before they become costly mistakes.

Each comparison on this page pulls from the same vendor-neutral, sourced definitions used throughout the MedTech Terms glossary. You see the one-line summary, the formal definition, why it matters in practice, common pitfalls, and the primary sources (FDA guidance, EU MDR/IVDR articles, ISO/IEC standards, MDCG documents, IMDRF principles) that back each entry. That makes the comparison defensible in regulatory strategy memos, design reviews, and submission narratives.

Common comparison patterns

Regulatory pathway choice - 510(k) vs PMA, 510(k) vs De Novo, Abbreviated vs Special 510(k).
Quality systems - QSR vs ISO 13485, QMSR vs QSR.
Software classification - SaMD vs SiMD, Locked vs adaptive AI.
EU frameworks - MDR vs IVDR, CE Mark vs UKCA.
Cybersecurity artifacts - SPDX vs CycloneDX SBOM, CVE vs CVSS.
Post-market actions - Recall vs field action, Removal vs correction.

How to use this tool

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MedTech Terms is a vendor-neutral community resource sponsored by Blue Goat Cyber. Definitions are written for educational use and are not legal or regulatory advice.