New EU IVD regulations to cause translation headaches for device manufacturers

Attention IVD and medical device manufacturers: The EU has finally released the new regulations for in-vitro diagnostic products on the European market. The long awaited and potentially costly changes will cause much concern as is but there is one area device manufacturers may have yet to consider - language translations.

While some of these regulations may seem familiar given that they've been previously released as guidances, the European Commission is now requiring that device manufacturers and medical translation providers take notice, and implement these requirements to avoid delayed time-to-market.


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