Labeling and Instructions for Use (IFU)
Labelling and Instructions for Use (IFU) are critical components of regulatory compliance for any medical or in vitro diagnostic device. These elements must not only meet the legal requirements set forth by Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR), but also ensure clear, accurate, and safe communication with end users.
We provide specialised support in the assessment and development of labelling and IFUs, ensuring that all mandatory elements are present, the language is appropriate for the target audience, and that the commercial communication aligns with the limits established by the applicable regulations.
Our services include
Technical review of labelling and IFUs
Technical review of labelling and IFUs to ensure full compliance with legal and regulatory requirements
Verification of mandatory content
Verification of mandatory content as per MDR/IVDR specifications
Linguistic adaptation of documentation
Linguistic adaptation of documentation for European markets, including translation and validation into European Portuguese and other official EU languages
Recommendations on formatting and graphical presentation
Recommendations on formatting and graphical presentation (legibility, layout, font size, symbols) in accordance with relevant harmonised standards
With our support, you can
Ensure your labelling and IFUs are clear
Ensure your labelling and IFUs are clear, complete, and legally compliant
Reduce the risk of non-compliance
Reduce the risk of non-compliance or user misinterpretation
Guarantee that your product communicates effectively
Guarantee that your product communicates effectively, safely, and transparently with the market, while also aligning with both regulatory expectations and your brand's quality and marketing standards
