Language Lessons

Manufacturers of in-vitro diagnostic (IVD) products face a variety of challenges in today’s marketplace: escalating regulatory requirements, reduced access to funding in a tough economy and a rapidly evolving market that requires significant R&D investment. For companies with international sales, these difficulties are amplified by an entirely different set of rules and regulations.

One such set affecting IVD companies selling into the European Union (EU) is the In Vitro Diagnostics Directive (IVDD), which is the last of the three stages of the Medical Device Directive (MDD) to be implemented. The first two stages of the MDD have already seen their compliance deadlines pass—the Active Implantable Medical Device Directive had an implementation deadline of January 1, 1995, and the Medical Device Directive deadline on June 13, 1998. After December 7 2003, all IVD products must be CE marked or they will be prohibited from being sold in EU nations.

CE marking IVD products for Europe is a complex task. As a part of the CE marking process, manufacturers may potentially have to translate a myriad of documentation, packaging and labeling into the native language of the market where the products will be sold. There are exceptions, and the rules are not always clear. Moreover, they may differ among EU member states.

Companies that fail to comply face a harsh reality—denial of access to one of the largest markets in the world. With 15 current member nations with a population of 360 million (and 10 additional countries invited to join starting in 2004), the EU includes some of the most lucrative markets for IVD manufacturers. But because of the EU’s diversity, companies face various language requirements for labeling and instructions. Obtaining a CE mark calls for not only translating product information from English to different languages spoken within the EU but also understanding of the nuances of each market.

The CE marking process for IVDs demands a concerted effort from many departments (regulatory, QA/QC, international marketing among others) within a company. Additionally, manufacturers have to decide whether they want to participate in some EU markets because of the added costs involved with CE marking. For some companies this arduous task will become a barrier to entry while others will benefit from less competition. In all cases, companies who want to sell in Europe will forever have to change the way they conduct business.

Time and Money

Companies that have CE marked their products understand that the process can require extensive work. Those starting the journey or planning to enter EU markets must approach the task with a comprehensive strategy. This means building a management and core support team, preparing a plan, determining resources and finances, establishing a timeframe and prioritizing products and markets. Achieving CE marking will be a lengthy process and cost a considerable amount of money. Companies need a clear plan to help them make a critical cost-benefit analysis.

In drafting the plan, manufacturers first determine which products to CE mark. With 13 languages spoken in the current EU and additional ones to come as Eastern European nations join, IVD manufacturers should investigate which markets are economically feasible. In addition to the initial marking costs, companies might have to change distribution and manufacturing to accommodate labeling requirements for a particular market. Labeling in five or six languages may cover 85% of a company’s European sales; performing a cost-benefit analysis of the remainder is necessary to determine the feasibility of labeling for those markets.

In addition to core products, manufacturers need to determine whether they need to CE mark accessories. Products may be grouped into families, which helps reduce the amount of documentation and translation required. Even core products can be grouped if a manufacturer can make a reasonable argument for the grouping. The grouping can be made by products or by technology. A set of analytes, for instance, can be grouped, and CE marked, together.

After choosing products for CE marking, companies must navigate some gray areas in the language requirements of the Directive. The IVD Directive provides room for interpretation, so manufacturers should show due diligence when making some of these decisions. For instance, regulators view products used by professionals differently than those for consumers. Professional technicians are trained, have more experience with IVD products and may even understand several languages. As a result, products marketed to them might require fewer translated instructions or labeling. On the other hand, consumer items require detailed, lucid instructions in the language of that market. If questioned by regulators, manufacturers must justify why they omitted some languages from their labeling.

A Thousand Words Worth: IVD companies can save verbage on packaging when they substitute symbols for words under the IVD Directive.

Regional Differences

While the Directive is EU-wide, there are differences in how each member nation adopts (transposes) the regulation. Some countries provide exemptions to local language requirements while others call for strict adherence to the Directive and may actually require that products be marked in several languages. For instance, Belgium requires labeling of professional products in French, Dutch and German but does allow exemptions if the professional user has an adequate knowledge of English, if she has been sufficiently trained or if the assay is routinely performed. Similarly, Greek authorities want instructions in Greek but allow other parts of the labeling in other languages. Luxembourg sanctions French, German, Luxemburger or English. As future members are added, IVD manufacturers should be aware of the requirements in those countries. Being informed about the national differences enables companies to determine if participation in a particular market is justified.

However, different rules apply to the translation of technical documentation. Notified Bodies, which CE mark high-risk products, need only one language. Also, manufacturers can use their best judgment as to what information is provided as part of the technical documentation. In some instances, excessive marketing material is included, which may raise the objections of regulators.

A particularly thorny issue is translating for Greece and other countries whose languages use an entirely different character set. Some manufacturers will find their labeling systems and databases aren’t capable of displaying these characters and must upgrade computer software and hardware.

Some manufacturers may be capable of performing all of the translation work internally while others will rely on outside services. There are no “right” vendors, but some key questions to pose include:

• What level of expertise do they have with IVDs?
• How are their linguists qualified?
• How is quality measured?
• Does the consultant have the appropriate resources for the project?

Making sure a vendor can provide timely and accurate service in the languages needed is critical to achieving CE marking.

Common Challenges

When it comes to product labeling, the Directive provides a framework based on established standards. The regulation refers to labeling as the label on the product and the instruction for use (IFU), including package inserts. Some of the standards referenced by the Directive include EN 980 (medical device symbols), EN 375 (professional use labeling), EN 376 (self-testing labeling), EN 1658 (marking of IVD instruments) and ISO 15223 (medical device symbols).

Labeling information—on the label or IFU—must include product name, name and address of manufacturer and authorized representative, if the product is sterile, use date, a statement indicating in-vitro use, an indication of whether the product is for performance evaluation, details for identifying contents, intended purpose and special handling and storage requirements. Because many IVD devices are packaged in small containers such as vials, only a small portion of this information may fit on the actual label; in these instances, the rest would be included in the IFU.

For products being distributed to numerous markets, how can multiple languages fit on the limited space of a label? The Directive allows the use of harmonized symbols to reduce text. Under EN 980, these established standards are universally accepted in EU countries. For instance, single-use products are indicated by an encircled “2” with a slash across it. These symbols are not only freely accepted as substitutes but encouraged by the Directive. Symbols are the most effective tools for shortening labeling and providing clarity to users.

Manufacturers should take caution, however, when applying widely used symbols that have not been harmonized. Even though they may be accepted in one market or region, authorities in other EU nations may question validity or require the IFU to explain their meaning. Furthermore, the FDA doesn’t accept symbols, although efforts are underway to gain acceptance.

 

Andres Heuberger

Andres Heuberger is founder and president of ForeignExchange Translations, Inc., a translation provider to the medical device and in-vitro diagnostics industries. He can be reached at [email protected].

When symbols can’t be used, manufacturers need to plot the best strategy for their targeted markets and change distribution accordingly. Will a single-language label be appropriate? If not, what about regional labels? If using generic pack-to-demand labels, can the local distribution point add country-specific information? Answers will depend on distribution capabilities, product use and user skills. Also, the best labeling strategy adopted today might not fit well into an expanded EU in the future, so IVD companies must think ahead.

One solution is to label the device with five or six languages and include a country-specific IFU, which also includes a translation of symbols.

Indicative of the digital age, some standards are starting to recognize the use of electronic IFUs provided through a CD-ROM or the Internet. While electronic data offer ease of distribution, they aren’t universally accepted. There may also be pragmatic limitation, say, in instances where users don’t have access to a computer or aren’t trained to use one. Regulatory authorities also have not agreed on accepting digital IFUs as a substitute for paper.

Ensure Accuracy

The Directive doesn’t specify color, font selection or size or how many levels of packaging should be used. This allows flexibility for designing labels and packaging that conform with a company’s corporate image. At times, companies sacrifice brand image for compliance, but the two aren’t mutually exclusive. Established templates and style guides help ensure adherence to a firm’s corporate image.

Companies should ensure the information to be translated is accurate and complete before beginning the process. Changes found after require exponentially more work because each alteration needs to be made to the source text as well as all targeted languages. This will hike up overall project costs and further delay compliance.

Clearly the IVD Directive will force companies to change the way they plan, manufacture, distribute and market products in Europe. Not only do they have to comply with the overall regulation but local variations as well when it comes to translations. Ironically, the EU’s intent of unifying the continent to a degree forces manufacturers to further segment the markets. Companies who want to continue to do business must be mindful of translation issues. Those who can do so with a concerted effort stand to reap the rewards of a market boasting a population that’s not only larger than the U.S. but also one that continues to expand with future members next year.