;   Medical Translation Insight: e-labeling, e-labeling, e-verywhere - ForeignExchange Translations

e-labeling, e-labeling, e-verywhere

After a long wait, e-labeling is everywhere (medical translation)For years, medical device manufacturers were wondering if e-labeling was ever going to become a reality in the EU. Then, earlier this year, the seemingly impossible did happen.

And now it looks like every regulatory authority across Europe is joining the fray. Eisner Safety reports that the UK MHRA (Medicines and Healthcare Products Regulatory Agency) "released a Guidance on EU Commission Regulation 207/2012 on electronic labeling of medical devices".

The guidance was published a few months ago and can be accessed via MHRA's website.

Device manufacturers are thrilled by all of this progress but for many medical device companies the question is no longer "when?" but "how?". If your organization needs help getting started with e-labeling, take a look at Medtronic's presentation, eLabeling in Europe -- How to Start and What to Expect from Notified Bodies.


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