How does the In-Vitro Diagnostic Medical device Directive effect a Non-European Manufacturer?

Manufacturers, as well as distributors, are now legally obligated to ensure that their products reside within the bounds of the Medical Device Directives and will be held responsible for not doing so. This includes informing the authorities about potentially dangerous supplies of your products, and can result in tracing your product to remove it from the market. The European market has the potential to be a very lucrative venue to sell your products; however, ignoring or failing to meet the regulations such as the Medical Device Directives can prevent the free-flow of your product or worse, remove your product from the market.

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