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COMMENTARY
Labeling for IVDs: Symbols to meet the needs of a multilingual market
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| Carolyn D. Jones |
The IVD Directive requires the use of local languages on products intended for the home-use market.2 Further, the directive allows competent authorities in each of the member states to decide whether their national languages must appear in the labeling of products for professional use.3
For IVD companies, the real estate available on product labels and containers is shrinking at an alarming rate. The proliferation of labeling requirements in the United States and abroad presents a challenge for manufacturers as they attempt to comply with both content-specific labeling requirements and the multilingual needs of the global marketplace.
Manufacturers have long anticipated that the European Union (EU) would require all IVD products to be labeled in each of its major languages (English, French, German, Italian, and Spanish), and they have similarly accepted the notion that products intended for the home-use market would need to be labeled in the local language of the consumer. At the same time, however, they have harbored the hope that the member states in the smaller language markets would not require the use of their national languages in professional-use product labeling.
That hope now seems futile. The reality is that both Denmark and Sweden, the first two member states to complete the transposition of the IVD Directive into national law, now require professional-use product labeling to be in their national languages.
In spite of the fact that the typical professional user in the European Union speaks and reads English, the majority of the EU's member states are expected to follow the Danes and Swedes by requiring translation of professional-use labeling and instructions for use into their national languages. Most countries would admit that such labeling requirements have been spurred by a need to express a sense of national pride while still fitting into a harmonized EU regulatory process. Nevertheless, the bottom line is that manufacturers may be required to label their products using as many as eleven different languages for the EU market alone.
For some companies, particularly small ones, the additional costs associated with the revision and translation of labeling or packaging may be prohibitive, resulting in either substantial price increases or reduced product availability for some less-lucrative markets. As manufacturers increasingly use tighter and smaller typefaces to accommodate multiple languages, it may also become more difficult for users to read the information on the labels.
In addition to the languages required in the EU, other languages may be required for Asia, South America, and the emerging markets of Eastern Europe. The requirement for Brazilian Portuguese has already been imposed from South America. These additional language requirements will place a further burden on the valuable space of IVD product labels and containers.
Although the use of multiple languages is not an issue in the United States, which is mostly a single-language market, the needs of the global marketplace still affect U.S. companies. To remain competitive, U.S. manufacturers must balance compliance with U.S. labeling requirements against the requirements of other markets. This was a difficult task before the IVD Directive and the explosion of other labeling initiatives. Now it may prove to be a virtually impossible task.
The European Commission believes that the way out of the labeling quagmire is for manufacturers to use symbols instead of words in multiple languages. In fact, the commission has mandated the use of symbols to support the essential requirements of the Medical Device Directive and the IVD Directive. The IVD Directive states that, "Where appropriate, the information to be supplied should take the form of symbols."4
Consistent with this recommendation, manufacturers are adopting the use of symbols—both to avoid the mandatory language requirements resulting from transposition of the IVD Directive and to address the labeling needs of other markets. For the most part, companies are using symbols developed by the standards community. Both the European Committee for Standardization (CEN) and the International Organization for Standardization (ISO) have developed symbols relevant to IVDs.5–7
The reaction of U.S. regulators to the use of symbols as an alternative means of satisfying IVD labeling requirements has been somewhat disappointing. Although FDA participated in the development and review of symbols relevant to medical devices and IVDs, through its participation on ISO technical committee (TC) 210, the agency has been reluctant to accept the use of symbols for IVDs without an explanation of each symbol in English.
In practical terms, providing an explanation as subtext would defeat the purpose of using a symbol. Valuable real estate would then be used simply to provide an explanation of the symbols. In addition, such a practice could open the door for other countries to require that a translation of each symbol be provided in their national language. In effect, industry would be back at square one.
There are signs that FDA's stance on the use of symbols may be changing. FDA has shown that it is amenable to the use of standards developed and approved by CEN or ISO. However, it remains unclear whether the agency's acceptance of such harmonized standards extends also to the use of symbols without explanatory subtexts.
Assuming that FDA does accept the use of harmonized symbols, manufacturers will have to work to alleviate concerns about the ability of their customers to understand those symbols. Initially manufacturers will have to provide a legend that explains the symbols, and they may need to employ a variety of other tools to educate their customers.
Symbols may never replace all of the wording required to be present on IVD product labels, but they can enable manufacturers to fit the required information on the product label or container. FDA acceptance of such symbols is important to the IVD industry. But with or without such acceptance, manufacturers must move forward with efforts to incorporate symbols into their labeling to meet the demands of a global market.
References
1. "Council Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on In Vitro Diagnostic Medical Devices," Official Journal of the European Community L331 (December 7, 1998).
2. IVD Directive, Article 4.4, Annex I.B.8.1.
3. IVD Directive, Article 4.4, Annex I.B.
4. IVD Directive, Annex I.B.2.
5. "Graphical Symbols for Use in the Labeling of Medical Devices," EN 980 (Brussels: European Committee for Standardization, 1996).
6. "Graphical Symbols for Use on Equipment—Index and Synopsis," ISO 7000 (Geneva: International Organization for Standardization, 2000).
7. "Medical Devices—Symbols to Be Used with Medical Device Labels, Labeling and Information to Be Supplied," ISO 15223 (Geneva: International Organization for Standardization, 2000).
Carolyn D. Jones, JD, is associate vice president for technology and regulatory affairs at AdvaMed (Washington, DC) and a member of the IVD Technology editorial advisory board.
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