Medical Device Symbols: What Each One Means and When It Is Enough
Updated: Aug 30
Medical device symbols do a specific legal job. They allow a manufacturer to supply information required by the regulation without printing that information in every language of every market the device reaches. That only works if the symbol used is one the reader is entitled to be assumed to understand — which is why medical device symbols are drawn from a standard rather than invented by the manufacturer.
The standard behind medical device symbols
EN ISO 15223-1:2021 is the standard that defines medical device symbols for use with information supplied by the manufacturer. Its reference has been published in the Official Journal of the European Union since January 2022, harmonised under both Regulation (EU) 2017/745 and Regulation (EU) 2017/746.
Harmonisation is what gives the symbols their legal effect. Using a symbol from a harmonised standard supports a presumption of conformity with the corresponding labelling requirement in Annex I, Chapter III of the regulation. Without that harmonisation, a symbol would be a graphic; with it, the symbol satisfies a requirement.
The standard organises medical device symbols by function rather than by device type. The groups cover manufacturing information, storage and handling conditions, safe use, sterility, in vitro diagnostic specific information, transfusion and infusion, and a residual group containing identifiers and product markings.
Medical device symbols that identify economic operators
Four symbols identify who is who in the supply chain: manufacturer, authorised representative, importer and distributor. Each appears alongside the name and registered address of the entity concerned.
These are the medical device symbols most often wrong on a label, and the reason is structural rather than careless. The supply chain changes. An authorised representative appointed in one year and replaced in the next leaves behind labels identifying an entity that no longer holds the mandate — and the entity named on the label is the one a competent authority will contact when it has a question.
A related change is worth knowing. ISO 15223-1:2021/Amd 1:2025 replaced the EC REP designation with a region-neutral EU-REP designation, because “EC” is the ISO 3166 country code for Ecuador and the original symbol could be misread. Labels already printed are not made non-compliant by the amendment, but artwork should be updated at the next planned revision.
Identifier symbols
The UDI symbol marks a carrier containing unique device identifier information. The MD and IVD symbols identify the item as a medical device or an in vitro diagnostic medical device respectively — a distinction that matters at customs and in procurement systems as much as in clinical use.
Catalogue number, model number, serial number and batch code each have their own symbol and their own defined meaning. They are not interchangeable, and using the batch code symbol where a serial number is intended produces a traceability record that does not do what it appears to do.
When medical device symbols must still be explained
Harmonisation removes the general obligation to explain standard symbols in the information supplied with the device. It does not remove that obligation in every case.
Where a device is intended for lay users, symbols are explained. Where omitting an explanation would increase risk — because the symbol conveys a warning, or because the intended user population cannot be assumed to recognise it — it is explained. Whether either applies to your device is answered in your usability engineering file and your risk management file, not by assumption.
This is the point at which manufacturers most often over-rely on the standard. Harmonisation is a presumption, not a blanket permission.
Implant cards
Article 18 of Regulation (EU) 2017/745 requires manufacturers of implantable devices to provide an implant card together with information enabling identification of the device. Symbols intended for use on implant cards were developed specifically for that purpose and are not simply the label symbols reproduced at a smaller size.
Implant card content and format should be read together with the applicable MDCG guidance rather than derived from the standard alone.
Practical checks before a label goes to print
Confirm the entity names and addresses beside the economic operator symbols match the records registered in EUDAMED. A mismatch between label and database is visible to anyone who checks both.
Confirm the symbol set used is from the current version of the standard, including the 2025 amendment. Artwork libraries drift, and a template that was correct in 2022 may no longer be.
Confirm the decision on whether symbols need explanation is recorded somewhere. “We did not think it was necessary” is not a position that survives an audit; a documented usability assessment is.
Sources
EN ISO 15223-1:2021, harmonised under Regulation (EU) 2017/745 and Regulation (EU) 2017/746, Official Journal reference published January 2022
ISO 15223-1:2021/Amd 1:2025
Regulation (EU) 2017/745, Article 18 and Annex I, Chapter III
MDCG 2021-5 Rev. 1 and its Appendix — harmonised standards
MDCG 2019-8 — guidance on implant card relating to application of Article 18
Who wrote this
Medex is a medical device manufacturer established in Ankara and a registered authorised representative in EUDAMED under SRN TR-AR-000057550. We are not a law firm and do not provide legal advice. Send us your device list and we will respond in writing.
The name beside the EC REP symbol has to match the representative registered in EUDAMED. When a manufacturer changes representative, the label and the database change together — see our authorised representative service.
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