Labeling requirements for medical devices in Ukraine are not specified in single legal act, thus Cratia decided to study that subject in details and prepare analytical review on necessary information, language, symbols and other requirements for labeling of medical devices and instructions for use (user's manuals).
Our analytical review has been published in "Apteka" magazine at June 29, 2013.
We have a specialist in our team that can review existing package labeling for compliance with legal requirements of Ukraine, prepare "Ukrainian" sticker with necessary information that will fulfill all requirements or localize package mock-ups.
Labeling carries very important information for a consumer that determines all necessary data for the safe and effective use of medical device. The correct labeling is highly important, in fact:
- incompliance of labeling requirements may result to stop/suspension the customs clearance of devices, cause loss of preferences for VAT;
- a market supervision foremost pays attention to information that accompany devices; incompliance can result to different consequences, up to suspension (termination) of Certificate of state registration of medical device;
- non-compliance with the requirements for labeling can result to an incorrect use of the device and cause of consumer complaints.
It is very important to determine definition of "proper labeling" for medical devices in Ukraine; to clarify what is necessary and what is only recommended to be displayed on the label of a medical device, how to develop a label with all legislative and legal acts, and relevant regulations, and to identify correct actions for approval of labeling example during registration. The main difficulty lies in the fact that the current legislation of Ukraine does not contain a unified definition of "appropriate labeling" of medical devices.
In contrast to the packaging of the medicinal product, which in the course of registration is subject to mandatory approval, labeling of medical devices remains at the discretion of the manufacturer and his representative, who must develop labeling information in accordance with legislation of Ukraine. At the stage of state registration of medical device (technical expertise) only the basic elements are reviewed and approved, but not all package labels.
Example of labeling of medical device considering requirements of State Standard of Ukraine EN 980:2007
Labeling requirements for medical devices are defined in a number of laws, decrees of the Cabinet of Ministers of Ukraine (CMU) and State Standards, which include both mandatory, such as:
- Law of Ukraine "On Protection of Consumers' Rights;
- Law of Ukraine "On the general safety of non-food products";
- Law of Ukraine "On the Principles of State Language Policy";
- Decree 1497 "On Approval of the Procedure of state registration of medical devices"
- State Standard of Ukraine (SSU) EN 980:2007 "Graphical symbols for labeling of medical devices";
- and other;
Labeling requirements set by obligatory rules must be applied to package label. While the voluntary standards are only advisory; they also become mandatory for certain products after the declaration of their compliance by the manufacturer during state registration of medical device in Ukraine.
The most important requirements:
The identity of the labeling information and information in the Certificate of state registration of medical devices is the most important requirement. Decree of the Cabinet of Ministers 1497 determines that the "importation into the customs territory, marketing and use of medical devices in Ukraine is permitted only after their state registration." Certificate of state registration contains a well-defined information about the product name, manufacturer's name and address, a catalog number can also be specified. Thus, during the customs clearance and market supervision it is checked whether the product is properly registered: compare of the information in the Registration Certificate with the data on the label and in the accompanying documentation is performed, and in the event of a slightest difference can be very difficult to prove that the product is registered.
|It is important to ensure that the information on the label is completely identical with the registration certificate: product name, name and address of the manufacturer, country of origin, catalog number (if specified). Attention should be paid to these requirements at the stage of state registration, while filling the Application and Annex (product list), registration materials (dossier).|
Labeling must comply with the requirements of the Law of Ukraine "On Protection of Consumers' Rights, Article 15 of which stated the right of consumers to information about products, namely:
- Product name, title or reproduction of the trade mark;
- Information about the basic properties of products, conditions of use and warnings about the use of certain categories of consumers, as well as other information that apply to a specific product;
- Information about the content of harmful substances, which are established by regulations, and warnings about the use of certain products;
- Date of manufacture;
- Information on storage conditions;
- Warranty obligations of the manufacturer (executor);
- Rules and conditions of the efficient and safe use of the product;
- Working life of the device, statements regarding handling by customer after it expire, as well as the possible consequences in case of non-action;
- Name and address of the manufacturer and the company that carries out its functions in relation to the claims from customers, as well as the repair and maintenance;
- Product’s certification information (if it is subject to mandatory certification);
- For product, which under certain conditions can be dangerous to life and health of the consumer and its property, to the environment, and the possible consequences of its use.
- While wholesale and retail trade is also necessary to specify the data of the price (tariff), conditions and rules of purchase.
Information on the impact of product on human life and health can not be attributed to the restricted information that establishes the requirements for the provision of full information about the risks of adverse events, and the warnings for use.
|Information defined by Article 15 of Law of Ukraine “On Protection of Consumer rights” is obligatory for package labeling and accompanying documentation (user’s manual and/or instruction) for medical devices; particularities of medical device should be considered.|
Information on the label must comply with the legislation on languages (language policy), which defines Ukrainian as the only official (governmental) language and a number of languages as regional languages. According to Article 26 of the Law of Ukraine "On the Principles of State Language Policy", labeling, instruction manuals, and so on must be labeled in state language and regional or minority language. By decision of the manufacturers next to the text in the official language, its translation into other languages can be placed.
|Text on the label, text of instruction for use (user’s manual) and other supporting documents for the use of a medical device must be provided in Ukrainian language.|
State standard EN 980:2007 "Graphical symbols for use in the labeling of medical devices" designed to establish uniform requirements for the labeling of both domestic and foreign medical devices (the identical translation of EN 980:2007 "Graphical symbol for use in the labeling of medical devices") and is recommended to the implementation. The standard specifies the graphic symbols, which are most often used by the manufacturer to provide information on medical devices and to reduce the need for multiple translations of words into different national languages.
General requirements to package labeling are examined during technical expertise (one of the steps of state registration of medical devices in Ukraine), as a result of such examination – example of package labeling is approved and attached to protocol of technical expertise. Starting from implementation of State Standard EN 980:2007 by default state experts recommend use of international symbols for labeling of medical devices to be applied. In case if Applicant accept (or in case if manufacturer already declares use of standard EN 980:2007) international symbols to be used – these requirements are approved in protocol of technical expertise and use of symbols becomes obligatory.
Brief content of State Standard of Ukraine EN 980:2007:
|Graphic symbol:||Symbol definition (according to DSTU EN 980) and explanation:|
|Repeated use is FORBIDDEN|
|USE BEFORE - This symbol is accompanied by a date that consists of four digits for the year, a two digits for the month, and, if necessary, a two digits for the day. The date should be placed out next to the symbol, or under it, or right of it.|
|LOT CODE - this symbol is accompanied by the lot (batch) code which must be combined with a symbol|
|REGISTRATION NUMBER - this symbol is accompanied by the serial number of device, which must be marked after or below than symbol|
|MANUFACTURE DATE - for the active implanted medical devices, a symbol will be combined with the date marked with four digits of year and two digits of month. For active devices a symbol must be accompanied by a year. A date must be placed after or below the symbol|
STERILITY - only for medical devices which is fully sterilized. Can be placed with clarification of methods of sterilization
|CATALOGUE NUMBER - the catalogue number must be placed after or below the symbol contiguous with him|
|WARNING! READ THE ACCOMPANYING DOCUMENTS - also can be the synonym of symbol "Attention, see instruction for use"|
|MANUFACTURER - this symbol must be accompanied by the name and address of manufacturer which responsible for product and must be placed after or below the symbol|
|THE AUTHORIZED REPRESENTATIVE IN EUROPEAN UNION - this symbol must be accompanied by the name and address of the authorized representative in European Union|
|CONTAINS SUFFICIENTLY FOR (n -) TESTS|
|ONLY FOR ASSESMENT OF WORK OF MEDICAL DEVICE FOR IN VITRO LABORATORY DIAGNOSTICS|
|MEDICAL DEVICE FOR IN VITRO DIAGNOSTICS|
TEMPERATURE LIMITATION - It may be applied only with the indication of upper or lower limit of temperature
|SEE INSTRUCTIONS FOR USE|
It is important to note that the State Standard EN 980:2007 is amended by a national mandatory extension, which has examples of the symbol "Number of Certificate of state registration of medical device in Ukraine":
With such normative explanation: «In Ukraine on package of medical device place out a symbol “Number of Certificate of state registration of medical device in Ukraine”. This symbol must be accompanied by the number of Certificate of state registration and date of its issuance. The registration number of certificate must be placed after a symbol, and date — below the symbol».
|It is obligatory to place the special symbol with a number and date of registration certificate in Ukraine on the individual packing of every device. If during technical expertise a labeling sample with the use of symbols according to SSU EN 980:2007 was approved, then the use of such symbols becomes obligatory also.|
All mentioned above symbols according to Ukrainian Standard EN 980:2007 we have drawn in vector graphic, ready for applying to package labeling for medical devices. Contact us to obtain these files.
Law of Ukraine "On Protection of Rights on the indication of origin of goods" determines mandatory indication of geographical origin of the goods. Thus, the country of origin, if different from the manufacturer specified in labeling, must be on the label, on the package of product:
It should be noted that the terms "manufacturer" and "country of origin" are not identical terms. According to European directives, the manufacturer is the company (person) who takes responsibility for the design, manufacture, packaging and labeling of the product prior to placing on the market (the EU), regardless of whether these operations are carried out on their own, or a third party. And the country of origin may be determined on the basis of substantial transformation, or the national share in the product value. Therefore, a company from Germany can place goods on the EU market and declare itself as the manufacturer, and the country of origin may be China, for example.
Mistakenly, the country of origin quite often is identified with the country of manufacture, while the registration certificate in Ukraine contains only the specific names, addresses, and country of the manufacturer. Thus, it is very recommended to include to registration certificate manufacturing sites of “main” medical devices (parts and disposables are considered from same country of origin while shipment with “main” device) according to countries of origin to avoid misunderstandings and problems during customs clearance.
|Indication of country of origin of medical device is obligatory. It is important to ensure during registration that the list of manufacturers includes not only sites that have provided relevant documents and appear on the label (with the names and addresses of the company), but also those that are indicated in the country of origin on the labeling.|
Other aspects of labeling of medical devices:
Product labeling with a registered trademark is regulated by the Law of Ukraine "On Protection of Rights in Trademarks" and provides for the application of this trademark on any product for which the mark is registered, on the package that contains a product, on the sign associated with it, label, badge, tag, or other object attached to the product, storage of such goods with the specified application of the trademark. Also, the above-mentioned Law provides that "A certificate holder has the right to affix a warning mark, which indicates that the trademark is registered in Ukraine."
Thus, trademark registration is voluntary and helps to protect the rights in the trade name or image. If the name of the product is registered without warning symbols ™ or ®, then place it to the labeling recommended only after the appropriate changes in the registration certificate.
Requirements to the font size of text labeling of a medical device are also not regulated, largely depends on the limitation of area for the application of this information and/or on discretion of the manufacturer or his representative, distributor. Representation of information in an accessible visual form is one of the basic requirements for the application of the information in the accompanying documentation and/or on the label, as well as in the labeling. Therefore, the font (size and type), a form of information representation should be available to the perception (i.e., person with normal vision should receive information without additional efforts or devices).
There is a following priority scheme for the right to apply a bar code on the product: the preference belongs to the owner of the brand, then – to the manufacturer, then - to the supplier. Although, article 5 of the Order No. 355 of 25.10.2007 "On Amendments to the Regulations on the bar coded goods" does not contain references to the mandatory use of the bar code on medical devices: "GS1 bar codes labeling is obligatory for alcoholic beverages and tobacco products, copies of audiovisual creations and phonograms, medicinal products and other goods, which are liable bar codes labeling under the legislation of Ukraine." None specialized regulatory document regulates the mandatory use of bar code, it can be applied at owner`s option, according to the above procedure in convenient linear or two-dimensional way.
Responsibility for the provision of appropriate information is shared between the manufacturer and the seller. The legislation does not specify who exactly - the manufacturer or the seller - is responsible, and because this issue requires determination of the Agreement.
It should also be noted that the standard EN 980:2007 in most European countries no longer valid from 01.01.2013 and was replaced in 2012 with the standard EN ISO 15223-1:2012. The new standard does not change the symbols EN 980:2007, and introduces some new characters.
Cratia is ready to assist you in review and development of package labeling for medical devices:
- review existing package labeling for compliance with legal requirements of Ukraine;
- prepare "Ukrainian" sticker with necessary information that will fulfill all requirements;
- localization of package mock-ups;