MDR/IVDR – adaptation of IFUs to the latest MDR/IVDR requirements
Adaptation of the product information for medical devices/
in-vitro diagnostics to the new MDR/IVDR requirements
Instructions for use (IFUs)
According to the new Regulations (EU) 2017/745 (MDR) and (EU) 2017/746 (IVDR), the “Instructions for Use (IFU) are of paramount importance because they have to be submitted as part of the technical documentation (product files) to the notified body or respective authority for registration.
The approved product information (IFUs) must be available to users in the respective EU languages.
- We review your IFUs.
- We adapt them to the new regulations.
- We translate them into any languages.
The mpü-experts know all the new requirements and will support you in adapting your documents to meet the new rules.
The right target language for every target market
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
These linguistic impacts demonstrate the important role that professional translations play in adapting to the new EU regulations of the MDR and IVDR.
Please get in touch if you are interested or have any questions or requests.
Please don’t hesitate to contact us for more detailed information on this comprehensive and topical issue.
