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When is software a medical device?

When is software a medical device?One of the most challenging components of the recently updated Medical Device Directive (MDD) 93/42/EEC is the increased focus on language translation for software and labeling.

For instance, the updated MDD states that software that is integral to the operation of a medical device must be translated into the languages of the countries in which the device will be sold. This leaves many device companies scratching their heads, or more likely, negotiating with notified bodies: Is our software considered a device?

Our friends at Eisner Safety Consultants can help with the answer.

COCIR, the European industry association representing the radiological, electromedical and IT industries, issued a decision diagram [PDF] to determine if software is considered a medical device per the MDD including the amendment.

The document was featured on Eisner's blog and includes a clear definition of what software includes, which is a wide range of items. Be sure to refer to the footnotes for some details that refer back to the MDD.

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ForeignExchange Translations provides specialized software translation and localization services to medical device companies. Contact us to learn more.


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