Gassing, I'm not sure that a lot of folks understand what CE approval means. It really has nothing to do with advanced technology. Many simple artifacts have a CE approval.
It really boils down to, doors the notified body consider that the product is safe to be used, in various situations. There needs to be a quality system in place, there needs to be a robust repeatable manufacturing design and process etc etc.
Once aCE is granted then the company can market the product within the restrictions that may be placed upon it.
Many products with a CE mark, fail in the market.
However out is a most important first step on a very long road to commercial success.
News: OncoSil Medical completes Fast Track Face-to-Face for CE Mark, page-19
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