;   Medical Translation Insight: 1 small step closer to e-labeling - ForeignExchange Translations

1 small step closer to e-labeling

We have previously called elabeling the "holy grail" of medical device packaging. A bit grandiose, maybe, but most device manufacturers do have several fingers crossed for a speedy introduction of elabeling regulations in Europe.

In late 2011, the EC has taken another small step in that direction. The EU Regulatory Committee on Medical Devices approved regulation on e-instructions for the use of medical devices.

The draft regulation sets out conditions according to which instructions for use (IFUs) in paper form may be replaced by electronic IFUs. It limits elabeling, however, to certain categories of medical devices and accessories. Furthermore, it contains a range of procedural safeguards (e.g., manufacturers have to provide paper IFUs upon request, conduct a risk assessment, and provide access information). The draft regulation also sets up a few basic safety requirements for web access.

We're still not there but at least it's progress. The regulation was submitted to the Council and European Parliament for review. Final publication was expected at the beginning of 2012.

It's now mid-February... does that still count as the "beginning of 2012"?

[Thanks to Eisner Safety for the heads-up!]

For more information about about elabeling, take a look at the following:
ForeignExchange Translations provides specialized medical translations for medical device IFUs, operating manuals, and product labels.


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