Belgium
National language(s): Dutch, French, German
All three languages for the lay person. One national language for the professional user in the language of the user. Exemptions are possible under certain conditions. A written agreement between the professional user and the Manufacturer stipulating another language (e.g. English) is acceptable. This agreement is kept at the disposal for the authority. Law of general rules for work protection must be taken into consideration.
Status: January 30, 2003

Denmark
Official language(s): Danish
Other languages may be accepted under “very” special circumstances for medical devices. An approval must be granted by the authority.
Status: July 17, 2003

Finland
Official language(s): Finnish and Swedish
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 AND Swedish.
The instructions for use and labeling of medical devices intended for self –testing must be in Finish AND Swedish. (Finish regulation 1506/94 as amended by 426/2000 unofficial consolidated and translated excerpt)
Status: May 8, 2001

Germany
Official language(s): German
Medical devices: Other EU languages may be used for non-safety data.
Medical devices can only be handed over to the user if the information for the user is in German. In certain (justified) cases a different language – for the user easy to understand - may be provided; information for the user may also be guaranteed by other measures (e.g. training, re-training, pictograms). In this case safety critical information has to be provided in German or in the language of the user. (German regulation MPG 2. Edition unofficial translation provided by MDSS. Please refer always to the original text)

Status: April 15, 2002

Greece
Official language(s): Greek
The information, which is included in the package insert and the instructions for use of the Medical Devices and IVDs, must be in Greek irrespective of being a device for professional or for patient use. Only the information on the label and outer package of a device for professional use can be in English. If the device is for patient use, the information on the label and outer package must be in Greek too.

Iceland
Official language(s): Icelandic
For the professional user other languages (e.g. Swedish, Danish, Norwegian, German, English) are accepted.
Status: June 1, 2001

Liechtenstein
Official language(s): German
Product information basically must be in German. However, English is accepted provided the product is used by experts who are proficient in English and who accept the language restriction. This must be evaluated from case to case and the following criterion must be fulfilled.

• The medical product is exclusively supplied to the professional user.
• It can be presumed that the user has the necessary professional and linguistic prerequisites and accepts the language restriction.
• The safety (protection) of patients, users and third parties is ensured.
• The operative and performance related use is not endangered.
• The preparation of German product information would cause a disproportionate amount of expenses.

Status: July 18, 2003

Luxembourg
Luxembourgish, French OR German for the lay person. English is accepted for professional user.
Status: June 19, 2003

Malta
National language(s): English, Maltese
Both national languages are accepted for the professional and the lay user. No other languages required.
Status: February 21, 2004

The Netherlands
Official language(s): Dutch
The information on a medical device made available to the user and patient (including label and instructions for use) must be in the Dutch language. Exemption can be granted by the authority to the manufacturer by meeting a number of requirements.
The information on in vitro medical Devices made available to the user and patient (including label and instructions for use) must be in the Dutch language. In cases where an in vitro diagnostic is exclusively delivered to an institution where the use of in vitro diagnostics takes place in a professional environment, the information may be in English, provided that the user has sufficient knowledge of the English language. The manufacturer has the responsibility to verify on a regular basis the knowledge of the English language and the professional use.
All information (i.e. labeling, instructions for use, etc.) concerning in vitro diagnostic medical devices which are intended to be used as self tests should be in Dutch.
(You may find additional information on the website of the Dutch Competent Authorities: www.igz.nl link ‘English’  medical devices)
Status: December 9, 2003

Norway
Official language(s): Norwegian
Medical devices shall bear or be accompanied by any information necessary for the safe use of the device taking into account the potential user’s educational background and level of knowledge. It shall be stated which language has been used to convey this information. Information accompanying medical devices to be used by patients, including devices for self-testing, shall be in Norwegian. (Norwegian regulation of 12 January 1995 No. 25 § 6)
Interpretation: Norwegian language is required for instructions when the actual user is a patient/a non-professional user. For professional use, it is not against the Regulation to offer information in a non-Norwegian language. English, Swedish or Danish will be understood by most. It is under the manufacturer’s responsibility to verify the language knowledge of the professional user whenever a foreign language is used. Please be aware that the State Labour Inspection may have special language requirements with regard to safety for the employees.
Status: July 3, 2003

Switzerland
Official language(s): German, French and Italian
The product information must be written in all three official languages. Official symbols can replace written information. Product information can be limited to less than the three official languages or be in English, provided:

a. The medical device is supplied exclusively to professionals or where the medical device is a custom made device;

b. There is assurance that the user has the necessary professional and linguistic qualifications, and agrees with the language restriction;

c. The protection of patients, users and third parties is nevertheless ensured; and

d. Effective and intended use is not jeopardized.

For software it is accepted that a single language is available (including English), as long as this is understandable to the user of the device according to the agreement between the user and the supplier of the device.
Status: June 18, 2003

In Austria, France, Ireland, Italy, Portugal, Spain, Sweden and UK only the national languages may be used.

The above information was collected from each European Competent Authority and is the interpretation of the national law. The wording may differ from the original text if no official translation of the law in English was available. Even though MDSS verified the contents with each Competent Authority, MDSS can not assume any responsibility regarding the stipulated requirements. Status as indicated in each section.

Return To Previous Page