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Translation and language solutions
for medical devices and in-vitro diagnostics
in each phase of the registration process


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.

Product information and labelling


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.



Product information

  • Instructions for use (IFUs)
  • Operating instructions
  • Device descriptions and manuals
  • Online help, online manuals
  • Marketing materials: flyers, booklets, brochures, posters, advertisements, promotional gifts


Labelling

  • Printing and writing on packaging, containers, devices, controls and screens
    (e.g. graphics, symbols, text)
  • Labels

 

Adaptation of medical devices/in-vitro diagnostics registered pursuant to the MDD/IVDD to the MDR/IVDR


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.

 

Translations - The right language for every target market


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

Feedback loop with country subsidiaries

  • Handling of communication and correction runs with the individual national authorities / distributors
  • Long-term optimisation of translation quality by using a feedback loop tool with access to
    client-specific translation memories and terminology databases


Range of services


Why mpü?

mpü is DIN EN ISO 9001 and DIN EN ISO 17100 certified and is synonymous with translation and process management of the highest quality.

  • Consulting for process definition/advising, setting up workflows
  • Creating a customer-specific process based on the initial situation
  • Risk management for the translation process
  • Translation of all documents in all languages
  • Consideration of all international and local regulatory requirements, norms and standards
  • Prompt delivery within the defined timeframes


  • Translations by linguistic and subject experts in medicine and medical technology (native speakers)
  • Revision in accordance with DIN EN ISO 17100 by a second independent language expert
  • 3-step quality assurance (QA) system in all languages with special QA processes and tools
  • Consistent quality / terminology in current and future projects throughout the company
    by using translation memory (TM) tools, quality assurance tools and
    customer-specific terminology databases
  • Foreign-language DTP and formatting as per the client’s specifications


  • Synchronisation / preparation of documents for different products within a product family
  • Securing data by using a separate translation server
  • Various price / service packages depending on your requirements or processes