The Global Advisor Newsletter - The IVD Directive. Language Requirements in the EEA (European Economic Area). Timing of Implementation. Advantages of Harmonization. Useful Links. Members of the European economic area (EEA)

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Other Editions

Seventeenth Edition

IVD Directive

Language Requirements in the EEA (European Economic Area)
Timing of Implementation
Advantages of Harmonization
Useful Links

Members of the European economic area (EEA) - Language Requirements

For information on language requirements refer to the map below and click on the appropriate country.

Country	Language		Comments
	For professional or non-safety related use	For patient safety use
Austria Back	For professional or non-safety related information: German	Information to ensure the safe use of the device by users or patients must be in German.	National language requirement.
Belgium Back	For professional or non-safety related information may use one of the following: Dutch, French or German, as required.	Information to ensure the safe use of the device by users or patients must be in Dutch, French and German (all required).	Approx. 57% of the population speaks Dutch (Flemish, Vlaamsch, Vlaams). French (Français) is spoken by approx. 33% of the population. German (Standard) is spoken by about 1.5% of the population.
Denmark Back	For professional or non-safety related information requires Danish.	Information to ensure the safe use of the device by users or patients must be in Danish.	National language requirement.
Finland Back	For professional or non-safety related information may use Finnish, Swedish or English. Info. may also be presented in the form of generally known directions or warning symbols.	Information to ensure the safe use of the device by users or patients must be in Finnish and Swedish.	Approx. 93.5% of population speaks Finnish. 6.5% of the population speak Swedish.
France Back	For professional or non-safety related information requires French.	Information to ensure the safe use of the device by users or patients must be in French	National language requirement.
Germany Back	For professional or non-safety related information may use German or other EU languages.	Information to ensure the safe use of the device by users or patients must be in German.	National language requirement.
Greece Back	For professional or non-safety related information requires Greek.	Information to ensure the safe use of the device by users or patients must be in Greek.	National language requirement.
Iceland Back	For professional or non-safety related information requires Icelandic or other languages that are understandable to the professional user, such as Finnish and Swedish.	Icelandic or other languages understandable to the professional user, such as Finnish and Swedish.
Ireland Back	For professional or non-safety related information requires English.	Information to ensure the safe use of the device by users or patients must be in English.	National language requirement.
Italy Back	For professional or non-safety related information requires Italian	Information to ensure the safe use of the device by users or patients must be in Italian.	National language requirement.
Luxembourg Back	For professional or non-safety related information accepts English.	Information to ensure the safe use of the device by users or patients must be in French, German and Luxembourgish.	French is the official language of legislative documents, and German is the most used language in the press, but Luxembourgish is the national language. It is spoken by about 300,000 people.
Netherlands Back	For professional or non-safety related information may negotiate English.	Information to ensure the safe use of the device by users or patients must be in Dutch.
Norway Back	May negotiate English.	Information to ensure the safe use of the device by users or patients must be in Norwegian.
Portugal Back	For professional or non-safety related information requires Portuguese.	Information to ensure the safe use of the device by users or patients must be in Portuguese.	National language requirement.
Spain Back	For professional or non-safety related information requires Spanish.	Information to ensure the safe use of the device by users or patients must be in Spanish.	National language requirement.
Sweden Back	For professional or non-safety related information may negotiate English.	Information to ensure the safe use of the device by users or patients must be in Swedish.
Switzerland Back	For professional or non-safety related information may use French, German or Italian. Romansch is also acceptable	Information to ensure the safe use of the device by users or patients must be in French, German and Italian - Romanish is also acceptable.	Romansch (aka Rhaeto-Romanic, Rhaeto-Romance, Romanche, Rumantsch and Rhaetian) is the name given to the Rhaeto-Romanic dialects spoken in Grisons, Switzerland. It is one of the country's four national languages along with French, German and Italian.
UK Back	Requires English on label, but other EU languages accepted on insert if the language is stated on the label.	Information to ensure the safe use of the device by users or patients must be in English on the label, but other EU languages accepted on insert if the language is stated on the label.

Timing of Implementation

According to Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical device, or IVDD for short, manufacturers may begin applying the CE mark to their products on June 7, 2000. The transition period ends on December 7, 2003, when the CE marking requirement becomes mandatory. Since the number of in-vitro diagnostic products is relatively small, there will not be an additional transition period for products already in the trade chain, as in the case of the MDD (Medical Device Directive).

Since the IVDD follows the implementation of two previous medical device Directives, European purchasers of healthcare products are well aware of the importance of the CE mark. Therefore, companies that procrastinate may find themselves at a competitive disadvantage, as hospitals are more likely to select products that carry the CE mark over those that do not.

Advantages of Harmonization

The IVD Directive harmonizes regulations throughout Europe. This may increase sales opportunities for manufacturers across the continent and encourage new exports.

Useful Links

Canon Publications - Medical Device Links
European Union
International Organization for Standardization
Medical Device Safety Service

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