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Primer: Why IFUs need to be translated

Primer: Why IFUs need to be translated (medical translation)Do operating manuals and instructions for use (IFUs) really need to be translated? In Europe and in many other countries around the world, the short answer is: Yes.

Many countries, e.g., Japan, China, Taiwan, maintain legislation that require that IFUs be translated into the national language.

In Europe, putting the CE mark on your product means that you conform to the rules, including translations. And the rules are outlined in Annex 1 section 13 of the Medical Device Directive (MDD): the IFU should be a document "...describing for the user the safe use of a medical device for the purposes designated by the manufacturer".

So, how much information is necessary to use the equipment in a safe way? The MDD provides some more guidance by stating (for example) that:

  • "(a)Each device must be accompanied by the information needed to use it safely..."

  • "(d) Instructions for use must be included in the packaging for each device..."

  • "(i) any special storage and/or handling conditions"

  • "(j) any special operating instructions"

  • "(k) any warnings and/or precautions to take"

The generally accepted interpretation of this is that all safety instructions must be in the national language of the user.

Is there a difference between professional and other users? Not in most countries. In transcribing the In-vitro Diagnostic Directive and MDD, some countries have excluded manufacturers of professional devices from the translation requirement. However, most countries treat all devices the same, regardless of whether they are for professional or other use.

Are there consequences if the IFU is not translated? In theory, yes. In practice, rarely.

Some countries have language on the books that provide for severe penalties if a manufacturer applies a CE mark without meeting the essential requirements. Here is an example from Sweden: "In accordance with the Medical Devices Act (1993:584) a fine and imprisonment of up to 1 year can be imposed for circumvention of the requirements and conditions for placing products on the market."

IFUs are considered part of the product and have to be produced using processes and quality levels identical to the "core" product. It's no wonder that writing and translating IFUs for an international audience is such an important and involved task!


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