Regulations & Standards

Published: June 1, 2003
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Labeling and language requirements under the IVD Directive

By: Andres Heuberger

Andres Heuberger is the founder and president of ForeignExchange Translations Inc. (Boston). He can be reached via andresh@fxtrans.com.

The IVD industry has been learning to adjust to the requirements of the European Union's (EU) IVD Directive (98/79/EC).1 One of those adjustments is in the area of labeling and language. As with the two previous directives for active implantable devices and general medical devices, the IVD Directive requires manufacturers to adhere to a set of regulations regarding labeling and language use. These new regulations are often ambiguous, and many IVD manufacturers are experiencing difficulties navigating through them.

The labeling and language requirements are spelled out in the essential requirements (Annex I) of the directive. These requirements are also supported by a number of other standards, such as EN 375/376 (information supplied with IVD reagents), EN 591/592 (instructions for use in IVD instruments), EN 1041 (information provided with medical devices), and EN 980 part 1 (graphic symbols for labeling medical devices).2

In essence, according to the directive, the labeling and language on each IVD device should provide the information needed to use the device safely and properly, and should take into account the training and knowledge of the potential users. This article further examines the labeling and language requirements that IVD companies have to meet in order to comply with the IVD Directive.

Labeling Issues

Many of the labeling elements that are required under the IVD Directive are similar to those required by FDA. According to the directive, the information required on labels includes:

  • Device name and description.
  • Name and address of manufacturer.
  • Name and address of authorized representative.
  • Lot or serial number.
  • "Use before" date.
  • Statement indicating in vitro use (where appropriate).
  • Statement indicating for self-testing use (where appropriate).
  • Storage, handling, and operating warnings.
  • Any residual risks.
  • Intended purpose.3

At the same time, while EN 1041 only specifies that "text must be readable" given a certain distance and lighting intensity, the directive does not specify any minimum font size nor address the use of color.4 In addition, the manner in which products are packaged is left to the manufacturer's discretion.

In those cases in which instructions for use must be included with the packaging of a device, the following information must also be provided:

  • All label information, except lot number and "use before" date.
  • Reagent composition.
  • Storage after opening.
  • Special equipment.
  • Specimen information.
  • Use procedure.
  • Measurement details.
  • Calculation principles.
  • Measurements needed for changes in analytical performance.
  • Pretreatment.
  • Packaging damage.
  • Reuse instructions (if applicable).
  • Date of issue and revision.5

Figure 1. Harmonized symbols that may be used on IVD labels and intructions for use.
(click to enlarge)

However, there are some substantial differences between the labeling requirements in the United States and those in Europe. First, the directive strongly encourages that wherever possible, the information on labels should be presented as harmonized symbols (see Figure 1). In contrast to FDA requirements, these symbols do not need to be accompanied by text explanations in Europe. Second, most EU member states' transpositions of the directive require labels to be translated into their national languages.

These additional requirements pose significant challenges to IVD manufacturers' labeling, packaging, and distribution systems. It is not often possible to include all of the product information in English on a small label. Doing so in multiple languages is even more challenging.

Using Symbols

When devising a global labeling strategy, particular emphasis should be placed on the following: evaluating the use of symbols to maximize label real estate; developing a consistent look and feel for labeling to maximize brand manifestation; planning for future languages to be added; and grouping languages together in a way that fits the company's distribution model.

The problem is that these considerations often conflict with one another, and there is no single correct approach. However, few would disagree that the use of symbols on labeling would solve many of these issues. The Global Harmonization Task Force has recommended:

 

The use of internationally recognized (i.e., standardized) symbols should be encouraged provided that device safety is not compromised by a lack of understanding on the part of the patient or user. Where the meaning of the symbol is not obvious to the device user (who, with some products, could be a member of the public), it should be described in words associated with the symbol.6

The major obstacle to the worldwide implementation of symbols is the reluctance of FDA to accept their use. FDA is concerned about the possible inability of the end-user to understand the symbols, which might result in an unsafe use of the product. The agency is also concerned about the constraints of current U.S. labeling regulations regarding words versus symbols. In fact, FDA may have a point. There is often nothing intuitive about the symbols used. Since few laypeople are familiar with their meanings, symbols do require some explanation.

Labeling Solutions

In their effort to meet all of the labeling requirements under the IVD Directive, IVD manufacturers have implemented one of the following approaches.

One size fits all. Fitting all of the languages and symbols onto one label is the least expensive alternative. It also facilitates packaging and label control. However, this alternative is often not feasible because of limited label real estate.

Regional labeling. Some IVD companies are considering using separate U.S. and non-U.S. labels. The U.S. labels would contain no symbols, and the non-U.S. labels for the rest of the world would contain symbols. While this approach may be easy to implement, it presents logistical problems for production planning and inventory control. For example, how many of each set of labels should be manufactured? How should back orders in one set be balanced against overproduction in another set?

On-demand labeling. This alternative calls for inventory to remain unlabeled until an order is received. Inventory is then labeled according to the requirements of each order, affording an IVD manufacturer greater flexibility. However, because inventory is handled more frequently, this approach can be time-consuming and expensive, and has the potential for causing inventory discrepancies.

Combined approach. Some IVD manufacturers have experimented with preprinting labels with high-demand languages while leaving space for another label for other languages that can be applied separately at the time of the order. This overlabeling offers better production planning and inventory control but does not eliminate the time and cost factors.

Whichever approach IVD manufacturers decide to adopt, it is important to consider the pros and cons of the solution as part of a risk analysis. Particularly important is the effect a failure in labeling could have on patients, users, and the environment. Overall, IVD manufacturers should not get hung up on finding the ideal approach to labeling. Instead, manufacturers should focus on getting the job done in a way that works with the company's specific products.

Language Issues

As stated above, the IVD Directive requires labels to be translated into the local languages of the EU member states. Because most U.S. firms tend to deal primarily with the domestic market, they have not had much opportunity to address these multilingual issues. As a result, many IVD companies do not understand fully the complexities of this language requirement.

The 15 current EU members use a total of 12 different languages. While the majority of these countries require translation into their national languages, the requirements often differ from country to country, depending on whether a self-test or professional-use device is involved (see Table I).

Country Language Requirement Notes
Austria German Requires use of national language.
Belgium Dutch, French, or German Any one of the above as required by the professional user and all three for patient use.
Denmark Danish Requires use of national language.
Finland Finnish, Swedish, or Engelish Information accompanying the device must be in Finnish, Swedish, or English, unless the information takes the form of generally known directions or warning symbols. Information intended for users or patients to ensure the safe use of the device must be in Finnish or Swedish.
France French Requires use of national language.
Germany German Other EU languages may be used for nonsafety data.
Greece Greek Requires use of national language for "instructions for use" documents. English is acceptable for labeling of professionally used devices and software.
Iceland Icelandic Other languages (e.g., Finnish, Swedish, English) understandable to professional user may be used.
Ireland English Requires use of national language.
Italy Italian Requires use of national language.
Luxembourg English English accepted for professional use; patient information in French, German, or Liezeburgish.
Netherlands Dutch Patient information must be in Dutch. English may be negotiated for professional use.
Norway Norwegian Patient information must be in Norwegian. English, Swedish, or Danish may be acceptable for professional use.
Protugal Portuguese Requires use of national language.
Spain Spanish Requires use of national language.
Sweden Swedish Generally requires use of national language. English may be negotiated for professional use.
Switzerland French, German, and/or Italian Product information may need to be written in all three languages for patients. The manufacturer decides whether language requirements have been met.
United Kingdom English Requires use of national language.
Table I. European language requirements (EU and EEA) . Source: IVD-Translation.com (www.ivd-translation.com/ivdd/languages.pdf).

Even though each IVD manufacturer's language strategy will be different, some of the steps that are taken are universally similar, including the following: analyzing a company's sales in Europe on a country-by-country basis (often the five or six languages already being used cover 85% of a company's market); analyzing the language requirements of the remaining 15% of a company's market versus revenues generated from that market; and determining if there are suitable exemptions in each of the national transpositions.

Dealing with Translation

Translation is at the heart of meeting the language requirements of the IVD Directive. Given what is at stake, developing a sound translation strategy is important, and choosing a proper translation partner must be researched thoroughly.

However, many IVD manufacturers and their staffs do not have sufficient experience and know-how regarding how to handle translation issues. Managers who are put in charge of dealing with translation typically do not have linguistic backgrounds and do not speak any foreign languages. These managers are handed the translating task on top of their regular responsibilities, leaving them to struggle to develop a strategy to multilingual documentation. As a result, managers have little opportunity to learn the correct approach to translation and end up reinventing the wheel as they go along.

Some IVD companies also seek ways to save short-term dollars by selecting the seemingly least-expensive approach to translation, such as awarding contracts to the lowest-bid vendor or using their distributors. By following these approaches, companies are not taking into account qualifications and are ignoring conflicting demands on internal resources. Industry consultants suggest that manufacturers should not ask their distributors to handle the translation efforts. Since these distributors may have a vested interest in a particular product, they will likely translate a text how they would like it to read, rather than how it should be read.

In addition, few IVD companies have instituted cross-departmental task forces to deal with translation and multilingual labeling. At those companies that have set up CE marking teams, translation issues are ignored until the last possible moment, and these teams generally find it difficult to work together.

One problem is that the roles of the teams are unclear. For example, in-country reviewers are usually not dedicated to proofreading translations. Other questions emerge about which functions should take precedence.

Choosing a Translation Firm

This lack of planning and communication at IVD companies regarding translation causes delays and cost overruns. This is especially true when the fit between a company and a translation vendor is less than ideal. To identify an appropriate translation firm, companies should consider the following.

Industry expertise. Since translation companies cannot handle every subject matter in every language, IVD manufacturers should demand specialization. Manufacturers need a partner that knows the industry, understands the jargon, and is up-to-date on regulations affecting the diagnostics industry. This can be accomplished by checking references or asking vendors to complete sample translations.

Linguistic qualifications. Just like the translation companies themselves, individual linguists must be specialized. Thousands of translators have their own areas of expertise. Qualified linguists must have a minimum of five or more years of professional translation experience; maintain excellent professional references; be certified by their national translators association; and successfully complete a subject-specific translation test.

Quality system. Since language is an art and not a science, it is impossible to specify what a perfect translation is. IVD companies can manage this subjectivity by implementing processes to document, measure, and audit translation activities. Companies should insist that vendors maintain auditable, documented quality systems. These systems should detail responsibilities, workflows, required documentation and approvals, as well as quality measurements. Several organizations, including the American Translators Association, publish standards for measuring translation quality.

Technology. While translation is still a human process, technology also plays important role. From translation memory tools (e.g., databases that make translated texts available for reuse) to multilingual desktop publishing systems and workflow management solutions, IVD manufacturers should look for a vendor that can deploy technologies to reduce costs and shorten cycle times.

Some IVD companies have combined these criteria into a comprehensive vendor-selection checklist. This checklist includes questions about the translation company (e.g., number of employees, years in business, clients), the type of translation software used, the use/non-use of in-country translators, the selection process for translators, and the company's pricing strategies.

One of the reasons why IVD companies should put a long-term translation strategy into place is that the list of languages requiring translation is expected to grow. By 2004, an additional 10 countries (Cyprus, the Czech Republic, Estonia, Hungary, Latvia, Lithuania, Malta, Poland, Slovakia, and Slovenia) will likely join the EU, and each will require the use of its own language on all IVD devices. In addition, three more countries (Bulgaria, Romania, and Turkey) are waiting in the wings for EU membership by as early as 2007.

Liability Considerations

While some countries will be more vigilant than others, it is anticipated that the competent authorities in most countries will not have the resources necessary to effectively police compliance to the IVD Directive for some time to come. Hence, the IVD industry will in effect be policing itself. According to industry analysts, competitors already initiate the majority of complaints made to EU competent authorities.

For example, in the UK, competent authorities have vowed to investigate every complaint made. The actions taken by competent authorities responding to complaints will be proportionate to the potential risk. At worst, it could be an immediate product recall. A best-case scenario might provide an IVD manufacturer the time needed to bring the labeling in line with the regulations.

Incorrect labeling, packaging, and instructions for use may lead to regulatory, criminal, or civil liability in the EU. If a device-related event leads to a product liability lawsuit, IVD manufacturers should be prepared to demonstrate that they have observed the proper practices in developing their labeling.

Conclusion

With the global demand for diagnostic products increasing, the ability to clearly communicate important product information becomes an increasing challenge. Such challenges have emerged in the EU, where multilingual labels and instructions-for-use documents have become a requirement under the IVD Directive. IVD manufacturers must decide on their own their global labeling strategies. While there is no universal approach that all companies can follow, the industry has been developing a number of best practices for label design and translation.


References

1. "Directive 98/79/EC of the European Parliament and of the Council," Official Journal of the European Communities 331 (1998): 1–37.

2. "Directive 98/79/EC of the European Parliament and of the Council, Article 4.4, Annex I, 8.1," Official Journal of the European Communities 331 (1998): 19–20.

3. "Directive 98/79/EC of the European Parliament and of the Council, Article 4.4, Annex I, 8.4," Official Journal of the European Communities 331 (1998): 20–21.

4. EN 1041, "Information supplied by the manufacturer with medical devices," Official Journal of the European Communities (1999).

5. "Directive 98/79/EC of the European Parliament and of the Council, Article 4.4, Annex I, 8.7," Official Journal of the European Communities 331 (1998): 21–22.

6. The Global Harmonization Task Force, Labeling for Medical Devices (2000) [cited 7 May 2003]; available from Internet: http://www.ghtf.org/sg1/inventorysg1/sg1-n9r6.pdf.

Andres Heuberger is the founder and president of ForeignExchange Translations Inc. (Boston). He can be reached via andresh@fxtrans.com.

Copyright ©2003 IVD Technology


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