An overview of medical device labeling in 2009.

The motto of the European Union (EU) is "united in diversity." With the ascension of Bulgaria and Romania in 2007, European multilingualism is recognized as 23 languages. These languages must meet three conditions: the language has to be officially recognized by a member state, indicated by its constitution; the member state requests and secures official language status at the EU level; and the other member states unanimously approve the request.

The European commissioner on multilingualism, Leonard Orban, shared a Czech proverb on his Web site: Those who speak several languages live several lives. Commissioner Orban purports that multilingualism is necessary for Europeans' identity and for "understanding and accepting others."

Languages According to the Medical Device Directives

The Medical Devices Directive MDD 93/42/EEC and the In Vitro Diagnostics Devices Directive IVDD 98/79/EC gave member states the latitude to require manufacturer-supplied information--Essential Requirements (ER), Annex I, 13 (MDD), and ER 8 (IVDD)--in their national language (MDD and IVDD, Article 4). Member states transposed the directives to require the manufacturer-supplied information in their national language. Not much has changed with this directive since the topic was featured in this column in April 2006. Thus, if a manufacturer wanted to market their medical device in all EU member state countries, the instructions for use must be in 23 languages.

Under certain circumstances, derogations are possible (i.e., a manufacturer may approach a competent authority and request an exemption to the official language requirement). This, however, typically is a Herculean feat, and best tried with an in vitro diagnostic medical device for professional use.

Symbols Are Desired

While multilingualism is pivotal to the success of the European community and is expected by the member states in manufacturers' information, it is balanced by the legislative preference to provide the information supplied by the manufacturer in the form of symbols. These symbols "must conform to the harmonized standards." (Paragraph 2 of Annex I, 13 and 8.)

Two new related standards (EN 980 and EN 1041) recently were revised in 2008 and are worth reviewing.

What Is Labeling?

Labeling is the information supplied by the manufacturer including the label (on the medical device and packaging) and the data in the instructions for use, as well as marketing materials. The topic of e-labeling generally has been equated with the computerized labeling of "electronically accessible information, CD/DVD-ROM, Internet or other mode." (EN 1041:2008.) Since the 2006 column, there have been developments worth discussing about e-labeling.

Harmonized Standards

The European Commission mandated that the European Committee for Standardization (CEN) prepare documents to support the essential requirements (ER) of the medical devices directives in the mid-1980s. To this end, CEN published both EN 980 titled "Symbols for Use in the Labeling of Medical Devices" and EN 1041 titled "Information Supplied by the Manufacturer of Medical Devices." The symbols in EN 980 were selected to convey some of the required information in the ER. Both of these standards were revised in 2008. Keep in mind that compliance with a European Norm (EN) harmonized standard published in the Official Journal of European Communities (OJEC) presumes compliance with the relevant ER (MDD and IVDD, Article 5).

Use of Symbols

There are many benefits to the use of symbols, since translating into the requisite member state official languages is resource intensive, exorbitant, and subject to error.

For all 27 EU member states, 23 languages would be required, but manufacturers that do not market a device in a particular member state do not have to translate into that state's official language.

Further, label space can be a commodity and lines of translated text occupy precious space and minimize readability. Symbols require less space and may convey information more readily and may be more aesthetically appealing. Most importantly, symbols facilitate the safety of the user and mitigate the manufacturer's risk, though before use, the manufacturer's risk assessment should deem it appropriate.

EN 980:2008

The most recent version of EN 980 was released last year. EN 980:2008 greatly expands the section on symbols already in use for medical device and in vitro diagnostic medical devices; these symbols have been "deemed to be suitable without need for further explanation."

The expanded version increases the number of symbols used from 12 to a total of 29. That total includes the original 12 symbols already established under EN 980:2003, 10 new symbols (under EN 980:2003), and seven symbols from ISO 15223-1:2007. One symbol adopted from ISO 15223, for example, communicates the warning "Do Not Resterilize" with a circle that contains the text "2 STERILIZE" and a diagonal slash through it. The benefits of using this symbol to indicate not to sterilize far outweigh those that might be gained from translating the warning into each of the desired official member state languages.

There are three symbols in EN 980:2008 that are part of the new symbols in the standard. These symbols fit into the anomaly of the standard and must be described when used.

Practical Notes About EN 980:2008

One of the features of EN 980 is the annexes that correlate the symbols in the standard to the explicit requirement of the ER which the symbol addresses. For example, the "Manufacturer" symbol in Section 5.12 addresses MDD, ER 13.3 (a) which requires that the name of the manufacturer be delineated on the label (and corresponding requirements in the ER IVDD and AIMDD). The symbols in EN 980 can be used to meet the information required on the label in ER 13.3.

Finally, the EN 980 symbols are not the only symbols that exist. A manufacturer certainly can fabricate its own or use symbols from ISO 15223, though the symbols in Section 5 of EN 980:2008 can be used without additional description since the standard is harmonized in the EU and published in OJEC.

EN 1041:2008

Standard EN 1041:1998 also recently was revised, but is applicable only to MDD. Despite the 10-year delay since the revision, not much has changed. Annex A in this standard, similar to the Annexes in EN 980, is extremely useful. The guidance clarifies that full postal addresses may not be required, but enough of the address needs to be provided so the physical location of the manufacturer and/or authorized representative can be contacted. Also, the post office box alone is inadequate. The standard also adds a section (Annex B) that addresses alternate labeling, and the term reflects the definition provided for e-labeling. Next month's column will address e-labeling in more detail.

While multilingualism is pivotal, symbols facilitate understanding as well, and with an increasing number of languages required to market to the EU, it seems prudent to avoid text when applicable.

Since symbols are encouraged, use symbols. Before using symbols, however, manufacturers should conduct a risk assessment to determine whether it is appropriate to use symbols without explanation. EN 980:2008 expands the number of symbols that can be used without explanation, except for the three anomalous symbols in the new section.

Not only do symbols reduce cost and mitigate risk, application of EN 980, which is an EN harmonized standard published in the OJEC, presumes compliance with the relevant ER. Clearly, there is an overwhelming benefit to using symbols, particularly EN 980 symbols.

Evangeline Loh, PhD, RAC is director of regulatory affairs for Emergo Group, an international consulting firm providing regulatory, quality assurance and distribution consulting services. Emergo has offices in the United States, Europe, Japan, China, Canada and Australia.Loh can be reached at [e-mail].