More medical device manufacturers are exporting to European markets than ever before.
Growth is fuelled by the explosion of the internet and European Union now having 28 member countries. This means a need to create larger ‘instructions for use’ and to accommodate more languages onto limited packaging space.
Medical device labelling and translation guidelines
We’ll help you reduce the cost of language translations and printing, but this should not be the driving factor. Safety is key to appropriate labelling. While you have a regulatory responsibility to ensure the safe use of your products, you also have a moral responsibility. It is important your risk analysis looks at what could happen if a user does not understand the labelling message. Could injury or death result? Then consider providing more information not less. This may mean using textual explanations instead of symbols.
With electronic labelling, you could supplement your paper instructions if it will improve safety and efficient use of your device. We’ll ensure translated versions of the current revision are readily available if needed.