Authorised representative (EC REP)
The standard’s wording, as the sources below reproduce it:
“Indicates the authorized representative in the European Community / European Union.”
ISO 15223-1:2021, 5.1.2
What it means for you
When the manufacturer is based outside the EU, EU law requires it to name a company inside the EU that acts for it with regulators. The name next to EC REP is that company. The 2021 edition widened the wording: Boston Scientific’s glossary reads “authorized representative in the identified jurisdiction”, so representatives for jurisdictions other than the EU use the same idea.
Whether a device is right for you is a question for your pharmacist, nurse or doctor.
- What it looks like
- A rectangle split into two cells: EC on the left, REP on the right, with a company name and address next to it.
- Where you see it
- Boxes of devices made in the US, UK, China and elsewhere that are sold in the EU — for example test kits, contact lenses and diabetes supplies.
- Other names
- EC REP; EU REP; authorized representative; European representative
What it does not tell you
It does not say the product was made or tested in Europe, and the representative is not necessarily the seller. A product from an EU manufacturer has no EC REP at all.
Often confused with
Indicates the entity importing the medical device into the locale.
More symbols in “Letters”
Sources
ISO 15223-1 is a paid standard, so the wording above is quoted as 4 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 EC | REP box for reference no. 5.1.2, “Authorized Representative in the European Community/European Union — Indicates the authorized representative in the European Community / European Union”. Checked 2026-09-25.
- Boston Scientific: Symbols Glossary — ISO 15223-1 5.1.2 “Authorized representative — Indicates the authorized representative in the identified jurisdiction.” Checked 2026-09-25.
- Cook Medical: Glossary of standard symbols — ISO 15223-1 5.1.2 “Authorized Representative in the European Community/European Union — Indicates the Authorized Representative in the European Community/European Union.” Checked 2026-09-25.
- BÜHLMANN Laboratories: Symbol glossary, version 03 (release date 2025-02-04) — “This symbol shall be accompanied by the name and address of the authorized representative, adjacent to the symbol.” Checked 2026-09-25.
Plain-language parts are in our own words; quotations are the sources’ wording.