As per the EU Medical Devices Regulation, users and patients are required to promptly report any significant events related to a medical device both to the device’s manufacturer and to the competent authority in the respective country where these events have occurred.
*Symbols may pertain to individual contents included within the device.
| Symbol | Symbol Title | Symbol Description | Standard Reference | Standard Title |
|---|---|---|---|---|
 | Non-sterile | Indicates a medical device that has not been subjected to a sterilization process. | 5.2.7 | ISO 15223-1:2021(E) Medical Devices – Symbols to be used with medical device labels, labeling and information to be supplied – Part 1: General Requirements |
 | Do not use if package is damaged and consult instructions for use. | Indicates that a medical device that should not be used if the package has been damaged or opened and that the user should consult the instructions for use for additional information. | 5.2.8 | ISO 7000-2606:2004-01-15 Medical Devices – Symbols to be used with medical device labels, labeling and information to be supplied – Part 1: General Requirements |
 | Temperature Limit | Indicates the temperature limits to which the medical device can be safely exposed. | 5.3.7 | ISO 7000-0632:2014-06-04 ISO 15223-1:2016 Medical Devices – Symbols to be used with medical device labels, labeling and information to be supplied – Part 1: General Requirements |
 | Do not re-use | Indicates a medical device that is intended for one single use only. | 5.4.2 | ISO 7000-1051:2004-01-15 Medical Devices – Symbols to be used with medical device labels, labeling and information to be supplied – Part 1: General Requirements |
 | Consult instructions for use or consult electronic instructions for use | Caution: Federal (US) law restricts this device to sale by or on the order of a physician. | 5.4.3 | ISO 7000-1641:2004-01-15 Medical Devices – Symbols to be used with medical device labels, labeling and information to be supplied – Part 1: General Requirements |
 | Caution | Indicates the need for the user to consult the instructions for use for important cautionary information such as warnings and precautions that cannot, for a variety of reason, be presented on the medical device Itself. | 5.4.4 | ISO 7000-0434A:2004-01-15 Medical Devices – Symbols to be used with medical device labels, labeling and information to be supplied – Part 1: General Requirements |
 | Medical device | Indicates that a given product is a medical device. | 5.7.7 | N/A |
 | Prescription only | Caution: Federal (US) law restricts this device to sale by or on the order of a physician. | – | Requirement for medical products sold in the US. |
 | Humidity limitation | Indicates the range of humidity to which the medical device can be safely exposed. | – | ISO 7000-2620:2004-01-15 |
