ISO 15223-1: The Symbols on a Device Label

ISO 15223-1 defines the symbols used on medical device labels, labelling and information supplied with the device.

The reason symbols exist at all is language. A device sold across the EU would otherwise need its label translated into every official language of every market it enters. A recognised symbol carries the meaning without translation, and the standard is what makes the symbol recognised.

The ones that appear on almost everything

• Manufacturer (a factory outline), with the name and address beside it.
• MD, indicating the product is a medical device. Required under EU MDR.
• EC REP, the authorised representative in the European Community, for a manufacturer outside the EU.
• UDI, the unique device identifier. See the UDI lookup tool for what a real one resolves to.
• Catalogue number, batch code, serial number.
• Use-by date, and date of manufacture.
• Do not re-use, a circled 2 with a line through it. One of the most commonly missed.
• Consult instructions for use.
• Sterile, with the method: STERILE R for irradiation, STERILE EO for ethylene oxide.
• Do not use if package is damaged.
• Caution, and temperature and humidity limits.

Why symbol review catches so many errors

Because it is detailed, repetitive, and usually done by eye.

A label goes through artwork, and artwork is typically owned by marketing, who own brand consistency and the design tools. Regulatory reviews the result. The errors that recur:

• The do-not-reuse symbol omitted from a single-use device.
• EC REP missing, or naming an entity that is no longer the authorised representative.
• The Rx only statement missing on a prescription device in the US.
• A symbol used without the standard reference where one is required, or without appearing in the instructions for use symbol glossary.
• The MD symbol absent on a product placed on the EU market under MDR.
• Address on the label not matching the registered manufacturer address.

None of these are conceptually difficult. They are missed because a person is comparing a hundred artwork files against a checklist, repeatedly, and attention is finite.

Symbols do not remove the text obligations

A symbol substitutes for text only where the regulation permits it. Some information must still appear as text in the required languages, and the instructions for use generally must explain every symbol used.

Under EU MDR, Annex I Chapter III sets the information requirements for the label and instructions for use, and ISO 15223-1 is the harmonised way of meeting part of them. Meeting the standard is not the same as meeting Annex I.