The comprehensive range of services offered by mpü translations for product information and labelling ensures solutions tailored to your requirements from the preparation and registration all the way through to the market launch of your products.
The individual stages of the process in our translation workflow guarantee that all deadlines and authority requirements will be met.
Thanks to our wide range of effective and cost-saving translation and localisation services, quality assurance measures and technical expertise, we will provide you with the results you expect.
As part of the device master file, the product information and labelling refer to the identification, the technical description and the use of the medical device or in-vitro diagnostic device. In other words, they include all of the written, printed or graphical information (per the MDR/IVDR requirements) about the device.
Instructions for use (IFUs)
According to the new regulation, IFUs are of paramount importance because they have to be submitted to the Notified Body or respective authorities for registration as part of the Technical Documentation (device master file).
The approved IFUs must be available to users in the respective EU languages.
We review your IFUs
We adjust them to the new regulations
We translate them into the desired languages
• Analysis of your IFUs in terms of the new MDR/IVDR
• Checklist and support during the adaptation phase
• Adjustment of IFUs to the applicable requirements
• Translation into all languages required
The mpü + orangeglobal experts know all the new requirements and will support you in adjusting your documents to meet the new rules.
If in doubt, please don’t hesitate to contact us for more detailed information on this comprehensive and topical issue.
The product information and instructions for use are required in the national language of the EU Member State where the product is to be marketed.
The Notified Bodies’ language list shows the languages which are mandatory for the product information and labelling in the respective country. MDEG - 2008-12 - II-6.3. Mandatory Languages Requirements for Medical Devices update Sept.08
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mpü is DIN EN ISO 9001 and DIN EN ISO 17100 certified and is synonymous with translation and process management of the highest quality.