Rules on the use of symbols in medical device packaging
The Food and Drug Administration (FDA) issued a set of rules on June 15, 2016, regarding using symbols in medical device packaging. The following are the new rules:
- Optional inclusion of graphical representations of information, or symbols, in labeling without adjacent explanatory text, also known as “stand-alone symbols,” is allowed if manufacturers meet particular requirements.
- The rule also provided that symbols accompanied by adjacent explanatory text continue to be permitted.
- The new rule also allows the symbol statement “Rx only” in the labeling for prescription devices.
The European Commission (EC), on the other hand, requires the use of “The Medical Devices Regulation” (MDR) issued in November 2021. This present guidance titled “Use of Symbols to Indicate Compliance with the MDR November 2021” has been updated to align with the new ISO 15223-1:2021.
The rationale for the use of symbols
Based on the guidance as specified in the preceding, there are 24 official languages in Europe. Without using symbols, manufacturers need to translate the information into different languages. The translation entails a lot of work and the use of time. Thus, the EC permits the use of symbols instead of written language on the labels of medical devices. The MDR regulation: Annex 1, Chapter III, 23.1h contains this specific permission. Manufacturers describe symbols as efficient, cost-saving, and internationally understood concepts to convey the required information to the users of medical devices.
Purposes of labeling and symbols
To identify the medical device and its manufacturer, to communicate safety and performance-related information to the user, professional, or lay—these are the primary purposes of having labels on the products.
This set of information needs to appear on the side of the device itself, on the packaging material, or as a separate sheet of paper titled “Instructions for Use.” The manufacturers need to adapt the materials used for printing, design, content, clarity, readability, and location of the label and instructions to the needs of the particular device, its intended purpose, and technical knowledge, experience, education, or training of the targeted user(s).
Specifically, the instructions for use need to be readily understood by the targeted user(s). Manufacturers may include and use drawings and diagrams to make them more transparent and understandable.
In addition, manufacturers can use internationally recognized symbols. Medical device regulators encourage this practice for as long as the device’s safety is not compromised. The meaning of the symbol(s) needs to be easily understood by prospective users. An explanation of the message of a particular symbol needs to be included in the instructions to clarify some unclear points.
Commonly used symbols
- Do not use if the package is damaged, and consult instructions for use. This indicates 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.
- Fragile, handle with care This indicates a medical device that can be broken or damaged if not handled carefully.
- Keep away from sunlight. This indicates a medical device that needs protection from light sources.
- Protect from heat and radioactive sources. This indicates a medical device that needs protection from heat and radioactive sources.
- Keep dry/Keep away from rain. This indicates a medical device that needs to be protected from moisture.
- Humidity limitation This indicates the range of humidity to which the medical device can be safely exposed.
- Do not re-use This identifies the devices which cannot be re-used, also as synonyms for “single-use,” “single patient use,” and “use only once”.
- Contains or presence of natural rubber latex For products containing natural rubber latex, which may cause an allergic reaction.
- Not made with natural rubber latex To indicate that the product is not made with natural rubber latex.
- Manufacturer This symbol shall be accompanied by the name and address of the manufacturer adjacent to the symbol.
- Date of manufacture This indicates the date when the medical device was manufactured. It should include at least a 4-digit year, followed by a 2-digit month and a 2-digit day (YYYY-MM-DD).
- Country of manufacture To identify the country of manufacture of products. In the application of this symbol, the “CC” shall be replaced by either the two-letter country code or the three-letter country code defined in ISO 3166-1.
- Authorized Representative in the European Community / European Union This indicates the authorized representative in the European Community, including the name and address.
- Sterilized using steam or dry heat This indicates a medical device that has been sterilized using steam or dry heat.
- Sterilized using ethylene oxide This indicates a medical device that has been sterilized using ethylene oxide.
- Sterilized using irradiation. This indicates a medical device that has been sterilized using irradiation.
- Do not re-sterilize. This symbol is not to be used on reusable medical devices that are intended to be sterilized between uses. This indicates a medical device that is not to be re-sterilized.
- Non-sterile This indicates a medical device that has not been subjected to a sterilization process.
- Consult instructions for use or consult electronic instructions for use. This indicates the need for the user to consult the instructions for use. When the instructions for use and patient information are located within the same electronic instructions for use, a manufacturer may choose to use this symbol to indicate both.
- Caution This indicates that caution is necessary when operating the device or control close to where the symbol is placed or to indicate that the current situation needs operator awareness or operator action to avoid undesirable consequences.
- Batch code This indicates the manufacturer’s batch code so that the batch or lot can be identified.
- Non-pyrogenic This indicates that the medical device is non-pyrogenic.
- Use by or expiry date This indicates the date after which the medical device is not to be used. (format date, YYYY-MMDD).
- Telephone This indicates the telephone number(s) to be used in contacting the manufacturer.
- Maximum quantity This indicates the maximum quantity the package can hold when transporting and storing.
- Contains or presence of phthalates (DEHP) This indicates that the product contains phthalates (DEHP), or DEHP is present in the product.