Can my medical device company obtain a CE mark before translating our documentation and packaging?
No. One of the criteria for obtaining a CE mark for medical devices and similar products is complying with individual country language requirements. In most cases CE requirements mandate that all packaging and instructions for use materials be translated into a national language if the product will be offered for sale in the country. What if we only want to launch our product in a few European countries initially? No problem. You can begin by translating for only those markets and simply expand as you go along. However, some companies plan ahead for future language needs. This allows them to get inserts translated (and resolve the associated technical, manufacturing and marketing challenges) up front and save time later. This approach also can save printing and production costs in the long run. Do you provide a certificate of translation accuracy? Upon request we will gladly provide a certification of our work. At the conclusion of every project, you will also receive a nonconformance
