In Ukraine there is no single document that summarizes all the requirements for the labeling of medical devices and instructions for use (user manual). The requirements are described in the Technical Regulations and other legislative acts, as well as in letters and recommendations of the central executive bodies (Ministry of Health, Ministry of Economy, State Medicines Service).
The labeling of a medical device is not registered by the certification body. The manufacturer and his Authorized Representative are responsible for ensuring that it complies with all applicable legal requirements.
The labeling is assessed by certification authorities, inspected by market control authorities (customs authorities) and market supervision authorities (State Service of Ukraine on Medicines and Drugs Control, State Consumer Service). Inappropriate labeling can lead to fines and restrictive measures.
Compliance of the labeling with all national requirements is an obligatory part of our work on conformity assessment (certification, registration) of medical devices in Ukraine, which we have been professionally performing since 2007. By starting cooperation with us, you will receive a high-quality and professional result.
The conformity mark (symbol of conformity to the requirements of technical regulations) is a symbol used by the manufacturer to indicate that the product complies with the requirements of Technical regulations of Ukraine. By affixing the conformity mark, the manufacturer or it’s Authorized Representative declares and guarantees that the requirements of all applicable national Technical regulations are met.
Medical devices may be subject to not only field regulation (such as Technical regulation on medical devices, medical devices for in-vitro diagnostics or active implantable medical devices), but also other technical regulations, for example, the regulation on restricting the use of hazardous substances in electronic and electrical equipment (UA RoHS2), regulations on radio equipment (UA RED) and others.
The form and description of the conformity mark, the rules for its affixing are described in the Resolution of the Cabinet of Ministers of Ukraine No. 1184. Technical regulations establish additional features and exceptions.
|Conformity mark for assessment route
without the involvement of a certification body
Conformity mark for assessment route
The height of the conformity mark (excluding the height of the body identification number) must be at least 5 millimeters. For small-sized medical devices, the size of the sign can be reduced. The conformity symbol should be in contrast to the background on which it is located (if necessary, it should be done in two contrasting colors).
Each separate (individual) medical device is subject to labeling with the national conformity symbol.
In the EU, the equivalent mark of conformity is the CE mark. In Ukraine, the CE-mark is not recognized and does not give the right to place medical devices on the market.
The requirements and approaches to the affixing of the CE mark and the Ukrainian mark of conformity are similar, but not identical.
CE mark - a mark of conformity
According to the requirements of the Law of Ukraine "On ensuring the functioning of the Ukrainian language as a state language" the labeling language is Ukrainian. Other languages are allowed.
Labeling of the medical device should include, but not limited to, the following information:
- The name of the medical device or data for its identification.The trademark is indicated in the language in which legal protection is given in Ukraine.
- Package content or product characteristics.
- Batch code or serial number (what is applicable).
- Expiration date (if applicable).
- The word “Sterile” and the method of sterilization (if applicable);
- Indication that product is intended for single use (if applicable);
- Mark of conformity to the requirements of technical regulations, certification body identification number (if applicable);
- Name and address of the Authorized Representative of the manufacturer in Ukraine;
- Information on special storage conditions (if applicable);
- Information on any precautions (if applicable);
- Manufacturer's name and address;
- Country of origin, if different from the country of the legal manufacturer.
Other information should also be indicated on the label, if applicable.
Units of measurement on the labeling of medical devices put into circulation from 01.01.2021 must be indicated using the International System of Units SI and described in the Order of the Ministry of Economic Development dated 04.08.2015 No. 914.
Ukraine has implemented national standard DSTU ISO 15223-1: 2015 “Medical devices. Symbols on the label of medical devices, marking and mandatory information”. This standard is identical to the international one and establishes graphic symbols for the labeling of medical devices. The use of these symbols allows you not to duplicate information in different languages.
Instructions for use (user manual)
Instructions for use are not mandatory for class I and IIa medical devices if such products can be used safely without such instructions. The instruction is included in the packaging of each medical device.
According to the requirements of the Law of Ukraine “On ensuring the functioning of the Ukrainian language as the state language”, the instruction must be presented in Ukrainian. Other languages are allowed.
Requirements for instructions are described in detail in the Technical Regulations and are individual for various types of medical devices.
Most frequently asked questions
1. Is localization of all package labeling required or is a sticker possible?
The use of the sticker is not prohibited, if that does not violate the integrity of the package and does not cover other information. For example, applying a sticker to sterile packaging would require additional data.
2. Who has the right to affix the labelling (sticker)?
Labelling is a function of the manufacturer. The conformity symbol is affixed to medical devices only at the discretion of the manufacturer. The manufacturer may outsource that function to the Authorized representative, importer or other organization to affix Ukrianian sticker, but that must be properly formalized, for example, by the Quality Agreement or the Appendix to the Distribution Agreement.
3. Is it possible to use electronic instructions?
The use of electronic instructions is possible if a number of requirements and conditions are met. The provision of instructions in electronic form should be limited to certain categories of medical devices intended for use in a specific environment.
4. What is the language of interfaces of medical devices and computer programs?
The interface language is regulated by the Law of Ukraine “On ensuring the functioning of the Ukrainian language as a state language”. To make a decision about the interface language, it is necessary to take into account the purpose, type of user and other aspects.
We have the necessary knowledge and experience to develop labels and instructions for medical devices in accordance with all national requirements.