Repackaging (open box, arrows, two boxes)
The standard’s wording, as the sources below reproduce it:
“To identify that a modification to the original medical device packaging configuration has occurred.”
ISO 15223-1:2021, 5.7.9 · ISO 7000-3727
What it means for you
The device is not in the maker’s original pack configuration — for example a box of 100 split into packs of 10 by a distributor. The company that did it is named beside the symbol.
Whether a device is right for you is a question for your pharmacist, nurse or doctor.
- What it looks like
- An open box with two arrows leading to two smaller closed boxes.
- Where you see it
- Split packs of dressings, strips or syringes sold by pharmacies and distributors.
- Other names
- repackaged by
What it does not tell you
It does not say the sterile barrier was opened — repackaging should keep it intact — and it does not change the use-by date.
Often confused with
To identify that the original medical device information has undergone a translation which supplements or replaces the original information.
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:
- NE Scientific: Master Symbol Glossary (CTF-100011 Rev 01) — Shows the open box with arrows to two boxes for reference no. 5.7.9 (ISO 7000-3727): “To identify that a modification to the original medical device packaging configuration has occurred”. 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)”: “These symbols have been developed for use by such entities to facilitate their compliance with the MDR.” Checked 2026-09-25.
- Integra LifeSciences: Symbols Glossary (1410819-2 Rev B) — “Repackaging — Indicates that a modification to the original medical device packaging configuration has occurred.” Checked 2026-09-25.
Plain-language parts are in our own words; quotations are the sources’ wording.