The Danish language is required for labelling and the instructions for use for all medical devices. This is regardless of the intended user's skills or profession. Therefore, the information necessary for the correct and safe use of devices must be in Danish when the device is made available to the final user.

According to the Danish transposition of:

• Directive 90/385/EC
  (The Ministry of Health and Prevention’s Executive Order No. 1264 of 15 December 2008 concerning active implantable medical devices)
  
  
• Directive 93/42/EC
  (The Ministry of Health and Prevention’s Executive Order No. 1263 of 15 December 2008 concerning medical devices)
  
  
• Directive 98/79/EC
  (The Ministry of the Interior and Health’s Executive Order No. 1269 of 12 December 2005 concerning in vitro medical devices)

The necessary information is described in:

• Directive 90/385/EC, Annex I, section 13-15.
• Directive 93/42/EC, Annex I, section 13. 
• Directive 98/79/EC, Annex I, part B, section 8.

The Orders do not require that software and service manuals must be provided in Danish. However, it is the manufacturer's responsibility to define which information is necessary for the correct and safe use of the device.

Display, buttons and keys

Single words or phrases such as "Load", "Enter", "Page Down" or the like, are considered to be symbols. Symbols are not required to be translated, but must be explained in the instructions for use.

If the information involves more than two words, and provides information / instruction to the user, this must be in Danish.