Marking medical devices is an essential manufacturing process that must be performed for all medical devices without exception. This step follows from the definition of the manufacturer according to Technical Regulation No. 753 on medical devices, namely: “manufacturer – a legal entity or an individual entrepreneur responsible for the design, manufacture, packaging and marking of the medical device before placing it on the market under its own name, regardless of whether these actions are carried out by that person or another person authorized to act on their behalf.”
The manufacturer is required to mark each released medical device with the necessary information for its identification and to affix the conformity mark to technical regulations. The first and foremost information that must be included on the label/marking of a medical device is the name and address of the manufacturer and authorized representative. If the manufacturer is not a resident of Ukraine, information about the authorized representative must be included. National standards do not provide for the presence of a symbol for the Ukrainian authorized representative, so this information is usually provided in writing.
Technical Regulation No. 753 on medical devices also specifies the need to indicate, if necessary, the word “Sterile”, the batch code, the single-use mark, and the expiration date to which safe use of the medical device is guaranteed. It should be noted that if the regulation states “if necessary”, it does not mean that the manufacturer decides whether to include this symbol or information on the marking or not, but indicates the obligation to include it if the product is sterile, has an expiration date or safe usage period, is for single use, has a batch code, or any other applicable “if necessary”. Any special storage conditions, usage instructions, and precautions must also be included in the product marking.
The regulation also contains requirements for indicating the intended purpose on the marking if its intended purpose is not obvious. All components of the medical device (more applicable to medical technology or systems that consist of several components) must be identified with batch numbers if provided. Special attention is given to custom-made medical devices and medical devices for Clinical Trials. Such devices must have a specific phrase indicating their status.
Familiarizing oneself with the requirements for marking and labeling medical devices, one can conclude that in some cases, a large amount of text is required. However, Technical Regulation allows for the use of symbols to reduce the amount of text on the marking and facilitate product identification for the consumer. For this purpose, we refer to the DSTU EN ISO 15223-1:2018 standard, which contains a number of symbols that can be used to simplify marking and improve product identification.
Below are examples of some symbols that may be used on the marking of a medical device, such as “Manufacturer”, “Use by”, “Do not reuse”, “Sterile”, “Use instructions” and “Do not reuse”.
According to the requirements of Technical Regulation No. 753 and standards, marking medical devices is an important element that ensures the safety and effectiveness of the product. Symbols and information on the label not only identify the device but also provide important instructions regarding its use, expiration date, and possible risks. Accurate and clear marking is a key element in ensuring the safety of patients and users of medical devices.
