EN ISO 15223-1:2016 is the 2016 edition of the medical device labelling symbols standard as adopted in the EU. This page explains the position of this edition, its relationship with the newer edition and where to obtain the official text.
About the standard
The 2016 edition was widely used during the era of the EU Medical Devices Directive (MDD). With the implementation of the MDR/IVDR, ISO has published ISO 15223-1:2021 and its 2025 amendment, adding symbols such as MD, UDI and importer, which are used as harmonised standards in the EU. Companies still using the 2016 symbols should update their labels against the new edition as soon as possible.
Applicable products and users
- Medical device labels still using the 2016 symbols
- Companies transitioning labels from the MDD to the MDR/IVDR
Main contents
- Scope of symbols in the 2016 edition
- Main differences from the 2021 edition
- Recommendations for transitioning labels from the old symbols to the new edition
Where to obtain the official standard
This standard is a copyrighted publication of the International Organization for Standardization (ISO) and related standards bodies. Please purchase or consult the official text through the following official channels:
- ISO Store: ISO 15223-1 (latest edition)
- BSI Knowledge (British Standards Institution): BS EN ISO 15223-1
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