While a significant percentage of doctors in the European Union speak and read English to a high standard, not all of them do. But more importantly, that figure is much lower among the general population and potential users of your medical device. What about the regulations though?
In a previous post we talked about some of the opportunities the European Union presents for US medical device firms looking to expand abroad, such as the unified regulatory approval process, but also the requirements for translation. Let’s take a closer look at those translation requirements.
In most EU countries, or if your medical device is intended to be used by patients or users from the general public, your firm will need to translate the patient or user information into the national language(s) of each EU country you intend to commercialize the medical device in. This information typically includes the instructions for use (IFU) as well as the device’s packaging and labeling. Translating this information allows those who will use the medical device to know how to properly use it.
That said, translation is not always mandatory. In a small number of EU countries, labeling in English only is permissible when the medical device is intended for professional use only.
Even if translation is not compulsory, however, there are other reasons for your medical device firm to opt for translating user information. Chief among them is exposure to liability. In the case of an injury or death associated with your medical device, choosing not to translate relevant information about the device can unnecessarily expose your firm to liability lawsuits or having to pay for damages. In addition, not translating patient information has the potential to prevent you from being covered by liability insurance. In other words, translating user information is an easy way to guarantee continued success for your medical device.
Translation doesn’t just help you speak your medical device user’s language and allow them to properly use the device; it helps ensure regulatory compliance and reduces liability exposure.
For additional information or to discuss your specific translation requirements, please get in touch at 212-355-4455 ext 208 or email@example.com.