Translation (A, arrow, other script)
The standard’s wording, as the sources below reproduce it:
“To identify that the original medical device information has undergone a translation which supplements or replaces the original information.”
ISO 15223-1:2021, 5.7.8 · ISO 7000-3728
What it means for you
Someone other than the maker — usually an importer or distributor — translated the label or instructions. EU law requires them to say so and to add their own name and address, which you will find beside the symbol.
Whether a device is right for you is a question for your pharmacist, nurse or doctor.
- What it looks like
- A box with the letter A, an arrow, and a second box with a character from another script.
- Where you see it
- Stickers on device boxes imported from another country, and translated instruction leaflets.
- Other names
- translated by; relabelled
What it does not tell you
It does not say the translation was checked by the manufacturer, and it does not change who made the device.
Often confused with
To identify that a modification to the original medical device packaging configuration has occurred.
More symbols in “Arrows”
Sources
ISO 15223-1 is a paid standard, so the wording above is quoted as 3 publishers’ public documents reproduce it. Each was fetched and read on the date shown:
- Boston Scientific: Symbols Glossary — ISO 15223-1 5.7.8 “Translation — To identify that the original medical device information has undergone a translation which supplements or replaces the original information.” Image labelled ISO 7000-3728. Checked 2026-09-25.
- NE Scientific: Master Symbol Glossary (CTF-100011 Rev 01) — Shows the A-arrow-script boxes for reference no. 5.7.8 (ISO 7000-3728). Checked 2026-09-25.
- MedTech Europe: Use of Symbols to Indicate Compliance with the MDR, version 3.0 (November 2021) — Section 8/9 “Translation (3728) & Repackaging (3727)”: MDR Art. 16(3) requires a distributor or importer that translates or repackages to indicate “the activity carried out together with its name … and the address at which it can be contacted”. Checked 2026-09-25.
Plain-language parts are in our own words; quotations are the sources’ wording.