Medical Translation Insight

Medical device manufacturers are struggling to determine just how broad the definition of "device" is when applied to their software. The answer to "What needs to be localized?" has far-reaching implications on development efforts, translation costs, and customer support.

The revised Medical Device Directive 2007/47/EC calls for translation of software intended for diagnostic or therapeutic purposes. It is important to note that it's not just patient-facing software but also other equipment or devices you might find in a clinic.

That is a broad category, open to interpretation, but one that device manufacturers don't want to get caught on the wrong side of. Some examples that we talk about are:

• Telemetry programmers
• Analyzer firmware
• PDA patient diaries
• Automatic external defibrillators
• Blood glucose meters

There would be very few examples where software would not have to be translated. Just like with the "old" MDD, KEMA's Eric Henning suggests that manufacturers get clarity (and agreement) from Notified Bodies before deciding on a course of action.

Making the wrong choice and not being able to defend your decision will be even more expensive and disruptive!


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