CE Mark - enables the product to be marketed in European Territories - occurred this year - see Annual Report
FDA clearance is required for US marketing.
In saying that companies will conduct pre-approval activity, so when approval has been gained then use can start pretty much on the day of approval. Which is what they will be talking about.
Like many approval authorities, it is notorious for delays, hence the fuzzy timeframe of sometime first half 2014. Symptom of underfunded government bodies.
I heard that the TGA (Australia) has about 10-20 people in it if that.
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